MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Silicone Flat Drain; Wound Drain

Catalog Number	0070370
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name: (b)(6) hospital.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 after product opening white foreign matter was found adhering to the tube.
Event or Problem Description
It was reported that after product opening white foreign matter was found adhering to the tube.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related, capa 14328472.Visual evaluation of the returned five-photo sample noted one opened (with original packaging), perforation silicone drain.Visual inspection of the first photo sample identified a perforation silicone drain contained within a sealed plastic sample bag.No visible external damage, deformation, fractures, or missing components were observed from the photograph provided.The second photo show the drainage tube with an excess silicone on the shaft.The third, fourth and fifth photo identified a small white foreign material-like appearance on the tubing at the indicated location.Product labeling was reviewed for this investigation.The reported event is addressed within the labeling.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.Corrections made to tab(s) d and 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.

• Brand Name: Silicone Flat 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, GA 30014 ; +1(770)784-6100
• MDR Report Key: 24030620
• Report Number: 1018233-2025-11666
• Device Sequence Number: 8998251
• Product Code: GBX
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2026

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: 0070370
• Device Lot Number: NGKR2468
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 05/07/2026; 08/25/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 05/14/2026; 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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