| Catalog Number |
0100L20 |
| Medical Device Problem Codes |
Decrease in Pressure (1490); Material Puncture/Hole (1504)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
04/17/2024
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 device was not returned.
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Event or Problem Description
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It was reported that the customer received a report of an indwelling catheter foley falling out.This was actually an issue in previous months as well, but at the time they did not save any product information so they could not determine if this was happening with medline or bard products.Although they could not verify the previous reports were involving the same skus, they do want to see if this was coming from a defective lot or perhaps a quality issue.They had the foley catheter and bag (soiled) in a biohazard bag in their office if it needs to be returned for investigation.Patient had catheter inserted in the operating room on (b)(6) 2024 during a kidney transplant case, reported falling out today.They received 4 reports from patient care units that patient¿s indwelling urinary catheters were falling out.In the most recent situation, apparently the patient heard a pop and then the catheter came out.Per follow up response received via email on 12apr2024, customer had not heard of another incident so hopefully this was just a defective run.The lot#ngfs3624 was the only lot# that they have confirmed as mentioned previously this did occur a couple times before, but the clinicians did not save the products for investigation.And originally, customer thought it was an issue with a medline catheter.There was not a report as far as a patient injury, they noted when it occurred the patient had heard a pop and then the catheter came out.Customer believed they had to have a new catheter placed.Per additional information received via email on 17apr2024, it was reported that they had some issues with kidney transplant patients experiencing catheters falling out days after the procedure.They had reported the first one and the second one was reported today but seeing as these were two different catheters.It was also noted that they had inflation volume of 10ml documented but which they were not sure if the 5ml on the material#(b)(4) signified the maximum inflation limit or maybe it was an over inflation issue.
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Additional Manufacturer Narrative
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The reported event was inconclusive because no sample was available for evaluation.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "water lost via permeation".However, there was insufficient information to confirm this potential root cause.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities: 3cc balloon: use 5ml sterile water; 5cc balloon: use 10ml sterile water; 15cc balloon: use 20ml sterile water; 20cc balloon: use 25ml sterile water; 30cc balloon: use 35ml sterile water; 40cc balloon: use 45ml sterile water; 75cc balloon: use 80ml sterile water; do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." 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 device was not returned.
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Event or Problem Description
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It was reported that the customer received a report of an indwelling catheter foley falling out.This was actually an issue in previous months as well, but at the time they did not save any product information so they could not determine if this was happening with medline or bard products.Although they could not verify the previous reports were involving the same skus, they do want to see if this was coming from a defective lot or perhaps a quality issue.They had the foley catheter and bag (soiled) in a biohazard bag in their office if it needs to be returned for investigation.Patient had catheter inserted in the operating room on (b)(6) 2024 during a kidney transplant case, reported falling out today.They received 4 reports from patient care units that patient¿s indwelling urinary catheters were falling out.In the most recent situation, apparently the patient heard a pop and then the catheter came out.Per follow up response received via email on 12apr2024, customer had not heard of another incident so hopefully this was just a defective run.The lot #ngfs3624 was the only lot # that they have confirmed as mentioned previously this did occur a couple times before, but the clinicians did not save the products for investigation.And originally, customer thought it was an issue with a medline catheter.There was not a report as far as a patient injury, they noted when it occurred the patient had heard a pop and then the catheter came out.Customer believed they had to have a new catheter placed.Per additional information received via email on 17apr2024, it was reported that they had some issues with kidney transplant patients experiencing catheters falling out days after the procedure.They had reported the first one and the second one was reported today but seeing as these were two different catheters.It was also noted that they had inflation volume of 10ml documented but which they were not sure if the 5ml on the material #0165l20 signified the maximum inflation limit or maybe it was an over inflation issue.
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Additional Manufacturer Narrative
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The reported event was inconclusive because no sample was available for evaluation.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿water lost via permeation".However, there was insufficient information to confirm this potential root cause.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities.3cc balloon: use 5ml sterile water.5cc balloon: use 10ml sterile water.15cc balloon: use 20ml sterile water.20cc balloon: use 25ml sterile water.30cc balloon: use 35ml sterile water.40cc balloon: use 45ml sterile water.75cc balloon: use 80ml sterile water.Do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ 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 or Problem Description
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It was reported that the customer received a report of an indwelling catheter foley falling out.This was actually an issue in previous months as well, but at the time they did not save any product information so they could not determine if this was happening with medline or bard products.Although they could not verify the previous reports were involving the same skus, they do want to see if this was coming from a defective lot or perhaps a quality issue.They had the foley catheter and bag (soiled) in a biohazard bag in their office if it needs to be returned for investigation.Patient had catheter inserted in the operating room on (b)(6) 2024 during a kidney transplant case, reported falling out today.They received 4 reports from patient care units that patient¿s indwelling urinary catheters were falling out.In the most recent situation, apparently the patient heard a pop and then the catheter came out.Per follow up response received via email on 12apr2024, customer had not heard of another incident so hopefully this was just a defective run.The lot#ngfs3624 was the only lot# that they have confirmed as mentioned previously this did occur a couple times before, but the clinicians did not save the products for investigation.And originally, customer thought it was an issue with a medline catheter.There was not a report as far as a patient injury, they noted when it occurred the patient had heard a pop and then the catheter came out.Customer believed they had to have a new catheter placed.Per additional information received via email on 17apr2024, it was reported that they had some issues with kidney transplant patients experiencing catheters falling out days after the procedure.They had reported the first one and the second one was reported today but seeing as these were two different catheters.It was also noted that they had inflation volume of 10ml documented but which they were not sure if the 5ml on the material#0165l20 signified the maximum inflation limit or maybe it was an over inflation issue.Per customer on (b)(6) 2024, it was reported that the patient was not injured and the lot number ngfs3624 was reported.
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Additional Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 or Problem Description
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|
It was reported that the customer received a report of an indwelling catheter foley falling out.This was actually an issue in previous months as well, but at the time they did not save any product information so they could not determine if this was happening with medline or bard products.Although they could not verify the previous reports were involving the same skus, they do want to see if this was coming from a defective lot or perhaps a quality issue.They had the foley catheter and bag (soiled) in a biohazard bag in their office if it needs to be returned for investigation.Patient had catheter inserted in the operating room on (b)(6) 2024 during a kidney transplant case, reported falling out today.They received 4 reports from patient care units that patient¿s indwelling urinary catheters were falling out.In the most recent situation, apparently the patient heard a pop and then the catheter came out.Per follow up response received via email on 12apr2024, customer had not heard of another incident so hopefully this was just a defective run.The lot #ngfs3624 was the only lot# that they have confirmed as mentioned previously this did occur a couple times before, but the clinicians did not save the products for investigation.And originally, customer thought it was an issue with a medline catheter.There was not a report as far as a patient injury, they noted when it occurred the patient had heard a pop and then the catheter came out.Customer believed they had to have a new catheter placed.Per additional information received via email on 17apr2024, it was reported that they had some issues with kidney transplant patients experiencing catheters falling out days after the procedure.They had reported the first one and the second one was reported today but seeing as these were two different catheters.It was also noted that they had inflation volume of 10ml documented but which they were not sure if the 5ml on the material #0165l20 signified the maximum inflation limit or maybe it was an over inflation issue.Per customer on 14may2024, it was reported that the patient was not injured and the lot number ngfs3624 was reported.
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Event or Problem Description
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It was reported that the customer received a report of an indwelling catheter foley falling out.This was actually an issue in previous months as well, but at the time they did not save any product information so they could not determine if this was happening with medline or bard products.Although they could not verify the previous reports were involving the same skus, they do want to see if this was coming from a defective lot or perhaps a quality issue.They had the foley catheter and bag (soiled) in a biohazard bag in their office if it needs to be returned for investigation.Patient had catheter inserted in the operating room on (b)(6) 2024 during a kidney transplant case, reported falling out today.They received 4 reports from patient care units that patient¿s indwelling urinary catheters were falling out.In the most recent situation, apparently the patient heard a pop and then the catheter came out.Per follow up response received via email on 12apr2024, customer had not heard of another incident so hopefully this was just a defective run.The lot#ngfs3624 was the only lot# that they have confirmed as mentioned previously this did occur a couple times before, but the clinicians did not save the products for investigation.And originally, customer thought it was an issue with a medline catheter.There was not a report as far as a patient injury, they noted when it occurred the patient had heard a pop and then the catheter came out.Customer believed they had to have a new catheter placed.Per additional information received via email on 17apr2024, it was reported that they had some issues with kidney transplant patients experiencing catheters falling out days after the procedure.They had reported the first one and the second one was reported today but seeing as these were two different catheters.It was also noted that they had inflation volume of 10ml documented but which they were not sure if the 5ml on the material#0165l20 signified the maximum inflation limit or maybe it was an over inflation issue.Per customer on 14may2024, it was reported that the patient was not injured and the lot number ngfs3624 was reported.
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Additional Manufacturer Narrative
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The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (without original packaging), used foley catheter.Visual inspection of the sample noted the catheter balloon was (in-house) syringe inflated with 30 ml methylene blue solution (3 drops 1 percentage aq methylene blue per 100ml distilled water) and no issues observed.Balloon rested with no leaks and concentricity was within specification.Catheter balloon deflated passively with no issues or cuffing.No root cause could be found because the reported event was unconfirmed.As the reported event is unconfirmed a labeling review is not required.As the reported event is unconfirmed a dhr review is not required.However, a dhr was completed before unconfirming the event.A labeling review is not required.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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Search Alerts/Recalls
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