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

Catalog Number	072221
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
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, during use, the needle was not sharp enough to pull out the catheter properly.
Additional Manufacturer Narrative
The reported failure could not be evaluated because functional testing was not possible and the device had met relevant specifications.Received (5) photo samples.The photo sample was returned and could not be evaluated for the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), silicone round drains with trocar needle (072221 and batch number ngjw3604).Visual inspection of the sample noted that the one-trocar point tip, and all edges were evaluated, and no burrs, nicks, distortion or dullness observed.The trocars appeared to be sharp.The investigation is inconclusive since only representative samples were returned for evaluation.This meets the specification "trocar point tip and all edges: shall be sharp, free of burrs, nicks and distortion, bent points are not allowed." per (b)(4).A labeling review was not performed because labelling could not have prevented the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: 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.
Event or Problem Description
It was reported that during use the needle was not sharp enough to pull out the catheter properly.

• 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: 22235368
• Report Number: 1018233-2025-04681
• Device Sequence Number: 9098325
• Product Code: GBX
• UDI-Device Identifier: 00801741049835
• UDI-Public: (01)00801741049835(11)241024(17)290831(10)NGJW3604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 072221
• Device Lot Number: NGJW3604
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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