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	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer was using a 19 fr wound drain and had to pull them from cases because the package contained a 15 fr drain instead.The staff pulled ten of these drains from the bin.The packaging was saying 19fr, but the drain was a 15fr size.
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 was using a 19 fr wound drain and had to pull them from cases because the package contained a 15 fr drain instead.The staff pulled ten of these drains from the bin.The packaging was saying 19fr, but the drain was a 15fr size.Per additional information received via mail on (b)(6) 2024, stated that there was no medical intervention reported and the device was replaced.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related (capa# 11207399).One photo was received for evaluation.It is evidenced the product label material #v072231 lot number ngjv0169.The root cause identified for capa 11207399 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.A labeling review, and dhr review are not required as capa 11207399 is applicable for this product lot number.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: 20818451
• Report Number: 1018233-2024-07651
• Device Sequence Number: 7683310
• 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: RI
• 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): 02/13/2025

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
• Date Returned to Manufacturer: 11/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 02/20/2025
• 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