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

Catalog Number	072229
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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 the bard product was much softer which was impeding the flow of drainage.The drain was unable to be sutured tight enough to hold the drain in place without causing a kink.
Event or Problem Description
It was reported that the bard product was much softer which was impeding the flow of drainage.The drain was unable to be sutured tight enough to hold the drain in place without causing a kink.Per customer follow up information received via email on 01dec2025, customer have attached the picture sent by the surgeon.It was their understanding that this was not just an isolated incident, but something experienced by their plastics group a few times in the past.This was the feedback received from one of their surgeons."bard drains was softer, they can¿t tie the suture as tight without risking completely kinking it off, and then because the suture was looser, the drain was at risk of pulling out.Customer attached the picture in that the suture was still in place, and the tubing has just slipped through it.This was a patient safety issue that puts the patient at a much higher risk of seromas and need to return to the operating room.
Additional Manufacturer Narrative
The reported event was inconclusive.The conditions of the sample did not allow further evaluation.Visual evaluation of the returned one photo sample noted one opened (without original packaging), used wound drain.Visual inspection of the one photo sample noted that unable to confirm the condition of the affected wound drain due to only photos provided for investigation.Further functional testing could not be performed if only based on the attached photos.Therefore, the reported event is inconclusive.The labeling is found to be adequate.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: d,h.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.

• 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, GA 30014 ; 7707846100
• MDR Report Key: 23390549
• Report Number: 1018233-2025-09583
• Device Sequence Number: 9983684
• Product Code: GBX
• UDI-Device Identifier: 00801741049897
• UDI-Public: (01)00801741049897
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/19/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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