MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION

Catalog Number	V0043610
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the drain was placed on a patient in (b)(6) 2023 in operating room and pulled at the bedside by the provider two days later.The following day the patient had a ct scan, and a 2 cm foreign body was noted.The patient returned to operating room and the foreign body was removed it was a drain fragment.The provider that pulled the drain believed the tubing was intact when they removed it, but they have found through their root cause analysis process that the tubing or drain broke during the removal of the drain.They did not have the original drain or tubing or the drain fragment but attached pictures of the same product used in its packaging as well as pictures of the drain fragment taken during the return to operating room.
Event or Problem Description
It was reported that the drain was placed on a patient in (b)(6) 2023 in operating room and pulled at the bedside by the provider two days later.The following day the patient had a ct scan, and a 2 cm foreign body was noted.The patient returned to operating room and the foreign body was removed it was a drain fragment.The provider that pulled the drain believed the tubing was intact when they removed it, but they have found through their root cause analysis process that the tubing or drain broke during the removal of the drain.They did not have the original drain or tubing or the drain fragment but attached pictures of the same product used in its packaging as well as pictures of the drain fragment taken during the return to operating room.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned photo sample noted one opened (without original packaging), used wound suction kit.Visual inspection of the photo sample noted the drain tubing was broken.This does not meet specification which states "break at perforated section".A potential root cause for this failure mode could be ¿tubing/wound drain is damaged".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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.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.0043600, 0043610, 0043620, 0043630: warning: this product can expose you to di(2-ethylhexyl) phthalate (dehp), which is known to the state of california to cause cancer and birth defects or other reproductive harm.For more information, go to: https://www.P65warnings.Ca.Gov.Note: in case drain should migrate, there is a white barium sulfate line on the entire length of the tubing that will show up on an x-ray." 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.

• Brand Name: CLOSED WOUND SUCTION
• Common Device Name: WOUND SUCTION
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18139547
• Report Number: 1018233-2023-08139
• Device Sequence Number: 12757957
• Product Code: GCY
• UDI-Device Identifier: 00801741051586
• UDI-Public: (01)00801741051586
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: V0043610
• Device Lot Number: NGHP0442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown