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

Catalog Number	V072231
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer went to open the package for a 19fr wound drain but when opened they were finding a 15fr.Per additional information received on february 3, 2025, it was reported that the particular wound drain had been opened to the sterile field for patient use, and upon physical touch, it was noticed that the drain was the wrong size (lot #: ngjv0169).The drain never made it in the patient and the device was replaced prior to insertion.Multiple 19fr drains had been labeled as 19fr and upon opening, it was a 15fr.They had different lot numbers (lot #: unk).
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.
Additional Manufacturer Narrative
The reported event is unconfirmd.Visual evaluation noted received 2 unopened channel drains with lot numbers ngjn2339 and ngjv0320 listed on the package.These lot numbers listed varies from the reported event as the reported event states the lot numbers are unknown.Packaging on both samples indicates the sample size to be 19fr.Using fr size gauge both samples received measured to be 19fr and would not fit into the 15fr gauge slot.Samples received match the pcn of the original complaint however it is unknown which lot number belongs to the complaint as both returned samples meet specification after testing.Therefore, the reported event is unconfirmed and no additional complaint is needed.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.No additional actions are required at this time.Correction: d,e,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 customer went to open the package for a 19fr wound drain but when opened they were finding a 15fr.Per additional information received on 03feb2025, it was reported that the particular wound drain had been opened to the sterile field for patient use, and upon physical touch, it was noticed that the drain was the wrong size (lot#ngjv0169).The drain never made it in the patient and the device was replaced prior to insertion.Multiple 19fr drains had been labeled as 19fr and upon opening, it was a 15fr.They had different lot numbers (lot#unk).Per additional information received via email on 01mar2025, it was reported that there were multiple lot numbers that were defective.Customer thought they placed 2 or 3 different ones in the box.

• 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: 21424079
• Report Number: 1018233-2025-01111
• Device Sequence Number: 7913359
• Product Code: GBX
• UDI-Device Identifier: 00801741119200
• UDI-Public: (01)00801741119200
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: V072231
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 08/03/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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