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

Catalog Number	0070430
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer had a serious concern with the wound drain, stating that a component of the product could be easily torn off, a piece of the product did break off based on the photo sample available potentially posing a patient safety risk.This issue had prompted two hospitals to consider pulling the product from use immediately.A previous response in april from a former representative claiming there was nothing wrong with the product had not been well received by the surgeon or the hospital¿s patient safety and quality department.Per additional information received on 19sep2025 via email, main complaint was the seam of plastic at the proximal portion of the drain had extra material that flaked off.Recreated with representative present on site.
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 was confirmed cause unknown.Visual (photo).One photo was received of the where it is visible that the seam of the plastic on the drain had material that flaked off.The reported event was confirmed.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, e, h.Udi format updated with available product information per gudid.H11: sections 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 had a serious concern with the wound drain, stating that a component of the product could be easily torn off, a piece of the product did break off based on the photo sample available potentially posing a patient safety risk.This issue had prompted two hospitals to consider pulling the product from use immediately.A previous response in april from a former representative claiming ¿there was nothing wrong with the product¿ had not been well received by the surgeon or the hospital¿s patient safety and quality department.Per additional information received on 19sep2025 via email, main complaint was the seam of plastic at the proximal portion of the drain had extra material that flaked off.Recreated with rep present on site.

• 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: 23178919
• Report Number: 1018233-2025-08689
• Device Sequence Number: 15913498
• Product Code: GBX
• UDI-Device Identifier: 00801741090752
• UDI-Public: (01)00801741090752(11)250426(17)300228(10)NGKQ2041
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/26/2026

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: NGKQ2041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2025
• 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