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| Model Number 0071370 |
| Device Problem
Material Fragmentation (1261)
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| Patient Problems
Unspecified Infection (1930); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 10/13/2021 |
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Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the drainage evacuator broke right at the joint between the translucent and white solid part.This was the second drain that was broken.Per follow-up information via email on 01nov2021, the photo was attached.The lot number was unknown.The product was used on the patient, there was no patient injury reported.The representative picked up one broken unit and that was not broken off in the patient.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: b, h h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that the drainage evacuator broke right at the joint between the translucent and white solid part.This was the second drain that was broken.Per follow-up information via email on 01nov2021, the photo was attached.The lot number was unknown.The product was used on the patient, there was no patient injury reported.The representative picked up one broken unit and that was not broken off in the patient.Per follow-up information via email on 01nov2021, it was stated that the drain was placed through the abdominal wall intraoperatively.It was ordered to be removed on post-operative day 6.When the nurse pulled on the drain, it came out easily, but did not have any portion of the white part of the drain attached.Also, stated that the patient required a repeat operation (laparotomy) to retrieve the white portion of the drain.This puts the patient at risk for poorer wound healing as a result and delayed recovery from the original operation.
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Manufacturer Narrative
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The reported event was confirmed cause unknown.One sample exhibited the reported failure.The device had not met specifications.The product was used for patient treatment or diagnosis.The product caused the reported failure.Visual evaluation of the photo sample noted one opened (without original packaging), used hubless silicone flat drain.Visual inspection of the sample noted that the white portion of the drain broke apart from the tubing.This does not meet the specification "drainage assemblies must be free of air, bubbles, cuts, smears and incomplete shots".A potential root cause for this failure could be ¿insufficient time or temperature to cure the drain¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "i.Device description: the davol® 400 cws closed wound suction evacuator kits contain wound drains and evacuators.Wound drains are made up of silicone or pvc materials; they are round shaped with perforations.They are packaged with a trocar.400 cc evacuators are made up of pvc materials.Clear evacuator sidewalls with volume calibrations facilitate examination and measurement of drainage fluid.Ii.Indications for use: wound drains are used to remove exudates from wound sites.Iii.Contraindications: do not use for chest drainage.Iv.Precautions: 1.Ensure that the wound site is dry and free of debris before closure.2.The surgeon must determine the number of drains needed for an effective drainage of the entire wound site.3.The junction between the tubing and tissue at the drain entrance site must be air-tight for effective functioning of the system.4.If the drain is occluded, irrigation and/or aspiration of the drain may be required.5.The quality and quantity of drained fluid must be regularly monitored and reported to the surgeon.6.Reservoir, once full, must be emptied per hospital protocols.Failure to do so will result in incomplete drainage.7.Suction must be discontinued prior to the removal of the drain.8.Before starting the drainage procedure, ensure that all the connections are tight and free of any obstructions within the drainage pathway.Connections to check are: i) drain to suction source.Ii) y-connector (when applicable): ¿ drain to y-connector.¿ y-connector to suction source.9.Di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks.V.Warnings: 1.An effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir must be maintained in order for the system to function properly.If the system is not maintained properly, surgical complications including hematomas may result.2.Blood collected using the evacuator must not be re-infused.3.Do not use in patients who are allergic to materials used in bard® drain products.4.Do not bypass or inactivate the anti-reflux valve.5.In the event of occlusion of the drain, all wound drainage ceases.Careful attention to the drain will minimize the probability of this problem.If occlusion does occur, the drain can be aspirated by connecting auxiliary suction to the reservoir outlet or temporarily disconnecting the drain from the evacuator and applying auxiliary suction directly to the drain.6.If an air-tight seal between the drain and the skin (from where the drain emerges) is not achieved, then air leak must be rectified or the system must be converted to open drainage.7.An airtight seal between all system components (drain, adapter, y-connector, crab-claw, evacuator and tube ends) is necessary for intended system function.8.Leaving the drain implanted for any period of time so as to cause tissue ingrowth around the drain can interfere with easy removal and may affect the performance of the drain.The surgeon should monitor the patient¿s rate of wound healing.9.Drain perforations must lie within the wound or cavity to be drained, otherwise inadequate drainage may result.10 to avoid the possibility of drain damage or breakage, please follow these steps: a.Avoid suturing through drains.B.Drains should lie flat and in line with the skin exit areas.C.Particular care should be taken to avoid any obstacles to the drain exit path.D.Drains should be checked for free motion during closure to minimize the possibility of breakage.E.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments as these could cause cuts or nicks and lead to subsequent structural failure of the drain.F.Surgical removal may be necessary if drain is difficult to remove or breaks.11.This is a single use device.Do not reuse.12.Do not re-sterilize.13.Trocar and evacuator are mr unsafe.Note: when using trocar with drain, care should be taken as the sharp and pointed edge of trocar could result in serious injury.After removal of trocar from the drain, please dispose of it as per the hospital protocol in the appropriate biohazard/sharps container." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that the drainage evacuator broke right at the joint between the translucent and white solid part.This was the second drain that was broken.Per follow-up information via email on 01nov2021, the photo was attached.The lot number was unknown.The product was used on the patient, there was no patient injury reported.The representative picked up one broken unit and that was not broken off in the patient.Per follow-up information via email on 01nov2021, it was stated that the drain was placed through the abdominal wall intraoperatively.It was ordered to be removed on post-operative day 6.When the nurse pulled on the drain, it came out easily, but did not have any portion of the white part of the drain attached.Also, stated that the patient required a repeat operation (laparotomy) to retrieve the white portion of the drain.This puts the patient at risk for poorer wound healing as a result and delayed recovery from the original operation.
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Manufacturer Narrative
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The reported event was confirmed and the cause was unknown.A potential root cause for this failure could be ¿insufficient time or temperature to cure the drain¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "i.Device description: the davol® 400 cws closed wound suction evacuator kits contain wound drains and evacuators.Wound drains are made up of silicone or pvc materials; they are round shaped with perforations.They are packaged with a trocar.400 cc evacuators are made up of pvc materials.Clear evacuator sidewalls with volume calibrations facilitate examination and measurement of drainage fluid.Ii.Indications for use: wound drains are used to remove exudates from wound sites.Iii.Contraindications: do not use for chest drainage.Iv.Precautions: 1.Ensure that the wound site is dry and free of debris before closure.2.The surgeon must determine the number of drains needed for an effective drainage of the entire wound site.3.The junction between the tubing and tissue at the drain entrance site must be air-tight for effective functioning of the system.4.If the drain is occluded, irrigation and/or aspiration of the drain may be required.5.The quality and quantity of drained fluid must be regularly monitored and reported to the surgeon.6.Reservoir, once full, must be emptied per hospital protocols.Failure to do so will result in incomplete drainage.7.Suction must be discontinued prior to the removal of the drain.8.Before starting the drainage procedure, ensure that all the connections are tight and free of any obstructions within the drainage pathway.Connections to check are: i) drain to suction source.Ii) y-connector (when applicable): ¿ drain to y-connector.¿ y-connector to suction source.9.Di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks.V.Warnings: 1.An effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir must be maintained in order for the system to function properly.If the system is not maintained properly, surgical complications including hematomas may result.2.Blood collected using the evacuator must not be re-infused.3.Do not use in patients who are allergic to materials used in bard® drain products.4.Do not bypass or inactivate the anti-reflux valve.5.In the event of occlusion of the drain, all wound drainage ceases.Careful attention to the drain will minimize the probability of this problem.If occlusion does occur, the drain can be aspirated by connecting auxiliary suction to the reservoir outlet or temporarily disconnecting the drain from the evacuator and applying auxiliary suction directly to the drain.6.If an air-tight seal between the drain and the skin (from where the drain emerges) is not achieved, then air leak must be rectified or the system must be converted to open drainage.7.An airtight seal between all system components (drain, adapter, y-connector, crab-claw, evacuator and tube ends) is necessary for intended system function.8.Leaving the drain implanted for any period of time so as to cause tissue ingrowth around the drain can interfere with easy removal and may affect the performance of the drain.The surgeon should monitor the patient¿s rate of wound healing.9.Drain perforations must lie within the wound or cavity to be drained, otherwise inadequate drainage may result.10 to avoid the possibility of drain damage or breakage, please follow these steps: a.Avoid suturing through drains.B.Drains should lie flat and in line with the skin exit areas.C.Particular care should be taken to avoid any obstacles to the drain exit path.D.Drains should be checked for free motion during closure to minimize the possibility of breakage.E.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments as these could cause cuts or nicks and lead to subsequent structural failure of the drain.F.Surgical removal may be necessary if drain is difficult to remove or breaks.11.This is a single use device.Do not reuse.12.Do not re-sterilize.13.Trocar and evacuator are mr unsafe.Note: when using trocar with drain, care should be taken as the sharp and pointed edge of trocar could result in serious injury.After removal of trocar from the drain, please dispose of it as per the hospital protocol in the appropriate biohazard/sharps container." the actual/suspected device was inspected.
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Event Description
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It was reported that the drainage evacuator broke right at the joint between the translucent and white solid part.This was the second drain that was broken.Per follow-up information via email on 01nov2021, the photo was attached.The lot number was unknown.The product was used on the patient, there was no patient injury reported.The representative picked up one broken unit and that was not broken off in the patient.Per follow-up information via email on 01nov2021, it was stated that the drain was placed through the abdominal wall intraoperatively.It was ordered to be removed on post-operative day 6.When the nurse pulled on the drain, it came out easily, but did not have any portion of the white part of the drain attached.Also, stated that the patient required a repeat operation (laparotomy) to retrieve the white portion of the drain.This puts the patient at risk for poorer wound healing as a result and delayed recovery from the original operation.Per additional information received via email on 01nov2022, stated that the patient had an abdominal operation on (b)(6) 2021 which required the post-operation use of two drainage bags manufactured by becton dickinson.During the post-operation recovery time in hospital, the first bag was removed 2 days prior to the planned discharge date.The second bag was removed on the day of their intended discharge, sunday (b)(6)2021.At that time, the patient was in high spirits and reasonable health, feeling confident to return home for the remainder of their recovery.At the time of the removal, which was performed by the attending nurse, the outer tube separated from the connector, leaving half the drainage tube assembly still inside the patient.The removal required an emergency surgery to extract the remaining parts by (b)(6) surgeon at st.(b)(6) hospital in (b)(6) canada.At the time, becton dickinson admitted liability for the defective drainage bag device, and it was taken out of circulation.This mishap was not due to the nurses' performance.Dr.(b)(6) and staff could provide further information for this conclusion if required.The result of this defective drainage bag and the second surgery was undue pain caused by a major infection, and other health issues including severely slowed recovery and inability to eat.This was also during the time of the covid-19 lockdown and ontario hospital restrictions limited patient visitation.Thus, family support was extremely limited.The massive infection that set in after the emergency surgery, measured 7cm in size with multiple tunneling lines, some reaching 3cm.The customer would like to state that the setback in recovery caused both physical pain as mentioned above, and severe mental anguish not only experienced by patient but also experienced by their immediate family.Understandably, this did not provide a positive mental state for recovery, which was in stark contrast to patient's state after the original surgery.The result was that this extended the patient's hospital stay to over three weeks, their weight also dropped to 89lbs, and the patient was sent into isolation because of the risk they might have developed c.Difficile.None of these issues had presented themselves after the original surgery.The issues did not stop upon release.The hospital needed the beds, so the patient was released to home care before the infection cleared.It took months for the infection to finally disappear.The patient's slow rate of recovery from the second surgery nearly precluded them from the ability to partake in chemotherapy post-surgery and did result in their inability to continue chemotherapy past one session because they were far too weak to continue.It has taken nearly one year of recovery for the patient to finally be in a position of health where they are now off most of their medication from both surgeries and could perform normal daily tasks without assistance.The customer would like to discuss compensation.The customer stated that they do not know what the failure rate of these drainage bags are but the above issues should never have occurred and that rate should be zero.At the time, bd representative asked the surgeon if they could get the customer's contact information to discuss compensation.However, the representative never contacted the customer, even though the customer stated that they would like to speak to representative.
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