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

Catalog Number	072186
Medical Device Problem Codes	Defective Device (2588); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
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 customer stated that they have received additional complaints with that wound drain, as well as identified that this may affect multiple items not just the originally reported.They need to set up a call, to discuss over that issue.They were looking at removing that product and others from inventory till they have an all clear.They mentioned impacted material below: material #072211, material #072190, material #072189, material #072214, material #072186.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted received 1 unopened channel drain.Upon opening packaging, dust particles and hair was present on the channel drain.Therefore, the reported event is confirmed and does not meet specifications which states "no hair is permitted on the product." and "product must be clean and free from oil or grease or loose foreign matter in excess of an aggregate total of 0.6mm² per tappi dirt estimation chart or 1/16in.In length.Labelling review is not required as labelling would not have prevented the reported event.Dhr review did not show any problems or conditions that would have contributed to the reported event.Correction: d, f, 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 the customer stated that they have received additional complaints with that wound drain, as well as identified that this may affect multiple items not just the originally reported.They need to set up a call, to discuss over that issue.They were looking at removing that product and others from inventory till they have an all clear.They mentioned impacted material below: material #072211, material #072190, material #072189, material #072214, material #072186.Per additional information received via email on (b)(6) 2025, it was reported that they shared clinicians raised multiple concerns related to item 072221 and then inspected similar items at their distribution center and found fuzzy hair foreign matter in those items as well.There was no harm to a patient as these were found before use.

• 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: 22794110
• Report Number: 1018233-2025-06713
• Device Sequence Number: 8315057
• Product Code: GBX
• UDI-Device Identifier: 00801741049682
• UDI-Public: (01)00801741049682(11)250213(17)291231(10)NGKN1717
• 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): 11/05/2025

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: 072186
• Device Lot Number: NGKN1717
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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