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

Catalog Number	072227
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that smmc had started receiving the bd drains and one of the surgeons was not happy with the 10mm fully fluted round wound drain from bd.He has said that he has had a patient with a hematoma caused by the drain.When look at the bd drain compared to the cardinal one, they were using the trocar was larger in diameter and the drain get larger where the flutes stop and the tubing begins.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported 1018233-2025-08306.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 smmc has started receiving the bd drains and one of the surgeons was not happy with the 10mm fully fluted round wound drain from bd.He has said that he had a patient with a hematoma caused by the drain.When look at the bd drain compared to the cardinal one, they were using the trocar was larger in diameter and the drain get larger where the flutes stop and the tubing begins.Customer email response received on 04nov2025.It was reported that a drain was available in their office.They are all the same, no particular lot.This was a design issue.They had another in their surgeon complained about the area where they would tie a suture, was too flimsy and will fold over or flatten out.No further details provided.

• Brand Name: CHANNEL DRAIN
• Common Device Name: CHANNEL 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, GA 30014 ; 7707846100
• MDR Report Key: 23179865
• Report Number: 1018233-2025-08705
• Device Sequence Number: 10074607
• Product Code: GBX
• UDI-Device Identifier: 00801741049873
• UDI-Public: (01)00801741049873
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 11/11/2025

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: 072227
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/12/2025
• 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: Unknown