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

Catalog Number	V072229
Medical Device Problem Codes	Defective Device (2588); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
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 issue first identified in february: we discovered that some drains labeled as 19f were actually 15f (lot # ngjv0169).Distribution and logistics team started checking lot numbers on all incoming shipments right away and 227 drains were removed from inventory.Bd was notified and samples of the affected drains were sent back to product analysis.Closure letter received: bd confirmed the mislabeling and sent a closure letter in june.At that time there were no additional complaints submitted for mislabeled drains.The product complaint was closed out.New drains found recently and customer submitted a product complaint on 7/23/25 for 10 additional drains that were found with the same lot number.
Additional Manufacturer Narrative
The reported event was confirmed by capa association to be manufacturing related as per capa #11207399 and sa number #(b)(6), the root cause identified is: the label process described in the procedure was not followed up by label printing technician, where established that before the printer is re-loaded with a new material lot, the label printing technician must take the first label of the at lot and mark with red ink the pre-printed material part number to confirm that it is according to the part number listed in operation 10 of the work order.This label should be signed, dated, and must be included in the dhr as sample; a comment documenting this material load should be added in the first article inspection form.As no sample was returned, based on the reported event, it is unknown which capa cause is most applicable to this event.A labeling review is not required because the investigation was confirmed by the capa association.A dhr review was not required because the investigation was confirmed by the capa association.A capa/sa 11207399/(b)(6) has been opened for this failure.Correction: f, h complete initial reporter facility name: (b)(6).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 issue first identified in february: we discovered that some drains labeled as 19f were actually 15f (lot # ngjv0169).Distribution and logistics team started checking lot numbers on all incoming shipments right away and 227 drains were removed from inventory.Bd was notified and samples of the affected drains were sent back to product analysis.Closure letter received: bd confirmed the mislabeling and sent a closure letter in june.At that time there were no additional complaints submitted for mislabeled drains.The product complaint was closed out.New drains found recently and customer submitted a product complaint on 7/23/25 for 10 additional drains that were found with the same lot number.

• 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: 22874532
• Report Number: 1018233-2025-06989
• Device Sequence Number: 5689791
• Product Code: GBX
• UDI-Device Identifier: 00801741119194
• UDI-Public: (01)00801741119194(17)290630(10)NGJV0169
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: V072229
• Device Lot Number: NGJV0169
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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