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

Catalog Number	0070430
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	08/19/2025
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 or manager at jupiter outpatient surgery center, reported a quality issue with bard wound drains, specifically involving white sticky foreign bodies.Described as silicone sliver found on the silicone tubing.These particles were located in various places and must be manually removed, which was both difficult and concerning from a clinical standpoint.The team, including surgeons, was uncomfortable with anyone handling the tubing once it was being inserted, due to sterility and safety concerns.
Event or Problem Description
It was reported that or manager reported a quality issue with bard wound drains, specifically involving white sticky foreign bodies.Described as silicone sliver found on the silicone tubing.These particles were located in various places and must be manually removed, which was both difficult and concerning from a clinical standpoint.The team, including surgeons, was uncomfortable with anyone handling the tubing once it was being inserted, due to sterility and safety concerns.Per notification from ucc on 08dec2025, it was reported that foreign white material present in opened returned samples was found during sample evaluation on 15oct2025.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received 6 unopened hubless silicone flat drain and 2 in opened packaging.Verified material number 0070440 and batch number ngkr3522.Visual inspection noted that there were white particles on the clear tubing.5 out 6 unopened hubless silicone flat drains had foreign white particle present foreign white material present in opened returned samples.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.No additional actions can be taken at this time.Correction: d,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 ; 7707846100
• MDR Report Key: 22849733
• Report Number: 1018233-2025-06886
• Device Sequence Number: 8403716
• Product Code: GBX
• UDI-Device Identifier: 00801741090752
• UDI-Public: (01)00801741090752(11)250522(17)300331(10)NGKR3522
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/17/2026

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: 0070430
• Device Lot Number: NGKR3522
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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