MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE ROUND DRAIN; WOUND DRAIN

Catalog Number	0070310
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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 wound drain was supposed to be 1/8 inch but came as 3/16 inch.The packaging stated it should be 1/8 inch.Customer had 2 came in this way with the same lot number.
Event or Problem Description
It was reported that wound drain was supposed to be 18/ inch but came as 3/16 inch.The packaging stated it should be 1/8 inch.Customer had 2 came in this way with the same lot number.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted received 3 unopened silicone round drain.On product packaging size is indicated as 1/8 per 10fr.For all samples, upon removing sample from outer packaging inner product packaging contained label indicated round drain 3/16.Using fr size gauge all samples received measured to be 16 fr size.The reported event is confirmed and does not meet specifications which states verify that unit label is correct.Based on the results of the investigation no additional actions are required at this time.Dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.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: SILICONE ROUND DRAIN
• Common Device Name: WOUND 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 30014 ; 7707846100
• MDR Report Key: 20925351
• Report Number: 1018233-2024-07985
• Device Sequence Number: 8285577
• Product Code: GBX
• UDI-Device Identifier: 00801741049460
• UDI-Public: (01)00801741049460(11)240925(17)290731(10)NGJV3680
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/21/2025

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: 0070310
• Device Lot Number: NGJV3680
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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