MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 CHANNEL DRAIN; WOUND DRAIN

Catalog Number	072229
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trocar had broken off shedding plastic into the patient's skin.The diameter of the drain itself was different than their prior cardinal one, and it was very painful to remove post operation in the office.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: leaving the soft silicone elastomer drain implanted for any period of time so as to cause tissue ingrowth around the drain can interfere with easy removal and may effect the performance of the drain.The surgeon should monitor the patient¿s rate of wound healing.To avoid the possibility of drain damage or breakage: drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Surgical removal may be necessary if drain is difficult to remove or breaks.Correction: a udi format updated with available product information per gudid.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 trocar had broken off shedding plastic into the patient's skin.The diameter of the drain itself was different than their prior cardinal one, and it was very painful to remove post operation in the office.Per customer via phone on (b)(6) 2025, it was reported that the patient was a female and there was no impact to them.They could not provide the lot number.Unfortunately, they could not provide more details and had already reported all the information that they knew.

• Brand Name: CHANNEL DRAIN
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21303178
• Report Number: 1018233-2025-00545
• Device Sequence Number: 15683959
• Product Code: GBX
• UDI-Device Identifier: 00801741049897
• UDI-Public: (01)00801741049897
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 072229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female