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

Catalog Number	V072229
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
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 19fr wound drain package contains 15fr drain.This was a patient safety concern because if surgeon did not notice and used this size expecting a larger one, the patient would not have the proper drainage they needed.This could be detrimental to the patient¿s recovery.The contact removed any they could find on the shelf and sent word to supply to remove from other locations.It was noted that the given lot# was ngjv0169.
Event or Problem Description
It was reported that 19fr wound drain package contains 15fr drain.This was a patient safety concern because if surgeon did not notice and used this size expecting a larger one, the patient would not have the proper drainage they needed.This could be detrimental to the patient¿s recovery.The contact removed any they could find on the shelf and sent word to supply to remove from other locations.It was noted that the given lot# was ngjv0169.
Additional Manufacturer Narrative
The reported event was confirmed by capa association to be manufacturing related as per capa #11207399 and sa number #ucc-25-5232-sa, 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 risk review and labeling review are 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/ucc-25-5232-sa has been opened for this failure.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: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 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: 21479857
• Report Number: 1018233-2025-01320
• Device Sequence Number: 20936186
• Product Code: GBX
• UDI-Device Identifier: 00801741119194
• UDI-Public: (01)00801741119194(11)240918(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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 02/07/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2024
• 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