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

Catalog Number	072221
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after bd representative had a call with customer and got some unfortunate news.After ordering more of the bd drains, end users have just found more of this contaminate.Bd representative just went back to the shelves and opened a new package and did find the white particles and hairs.Per follow information received on 12feb2026, bd sales team was on site with (b)(6) today to discuss the issue reported, related to foreign matter found on the wound drains.They provided the sales team with the impacted lot, which is ngkv4053, asked to ensure that is added to the record.Photos were also taken.Per photos sent by bd representative, the first one where the wound drain was out of the packet appeared to have a fuzzy on the outside (this doesn¿t really show up in the picture).Customer had these selected where it appeared there was debris inside the wound drain.They could not really see them inside the tubing, but they are going to send to covington in the return box that he was given.
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: sections 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 is confirmed - cause unknown.Evaluation determined the product does not meet specifications, and no product nonconformance was identified.Received (5) photo samples.The photo sample was returned and could not be evaluated for the reported failure.Received 1 opened and 3 unopened channel drains.All samples tested for "foreign material." channel drain 1: received 1 opened channel drain.Material number 072221 and batch number ngkv4053.Inspection noted no obvious observations.Channel drain 2: received 1 closed channel drain.Material number 07221 and batch number ngjx5747.Visual inspection noted some black debris on channel drain.Confirmed.Channel drain 3: received 1 unopened channel drain.Material number 072221 and batch number ngjp2050.Visual inspection noted no obvious observations.Channel drain 4: received 1 unopened channel drain.Material number 072221 and batch number ngks3088.Visual inspection noted lint on the white part of the drain.Confirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections made to tab 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 after bd representative had a call with customer and got some unfortunate news.After ordering more of the bd drains, end users have just found more of this contaminate.Bd representative just went back to the shelves and opened a new package and did find the white particles and hairs.Per follow information received on 12feb2026, bd sales team was on site with corewell health today to discuss the issue reported on, related to foreign matter found on the wound drains.They provided the sales team with the impacted lot, which is ngkv4053, asked to ensure that is added to the record.Photos were also taken.Per photos sent by bd representative, the first one where the wound drain was out of the packet appeared to have a fuzzy on the outside (this doesn¿t really show up in the picture).The customer had these selected where it appeared there was debris inside the wound drain.They could not really see them inside the tubing, but they are going to send to covington in the return box that he was given.

• 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: 24437461
• Report Number: 1018233-2026-01196
• Device Sequence Number: 10448745
• Product Code: GBX
• UDI-Device Identifier: 00801741049835
• UDI-Public: (01)00801741049835(11)250919(17)300731(10)NGKV4053
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/20/2026

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: NGKV4053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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