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

Catalog Number	0070370
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the four neuro surgery cases at (b)(6) hospital have experienced complications due to issues with the 10 mm flat drain (product code: 0070370).The tubing is reportedly flimsy and prone to crimping, which interferes with proper insertion.In one instance, the surgeon was unable to fully place the drain, raising safety concerns.As a result, four patients required return trips to the operating room, and one developed a hematoma.The issue appears to be linked to a product change that occurred over the summer, and the hospital is currently working with emr staff to retrieve the affected lot numbers.For further investigation and resolution, samples should be sent.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Initial reporter name: (b)(6).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 inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it states." caution: to avoid the possibility of drain damage or breakage: -additional perforations should not be made in the drains.-avoid suturing through drains.-drains should lie flat and in line with the skin exit areas.-particular care should be taken to avoid any obstacles to the drain exit path.-drains should be checked during closure for free motion to avoid possibility of breakage.-drain removal should be done gently by hand.They should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.A dhr could not be performed since no lot number was provided.Initial reporter name: (b)(6).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 the four neuro surgery cases at henry ford jackson hospital have experienced complications due to issues with the 10 mm flat drain (product code: 0070370).The tubing is reportedly flimsy and prone to crimping, which interferes with proper insertion.In one instance, the surgeon was unable to fully place the drain, raising safety concerns.As a result, four patients required return trips to the or, and one developed a hematoma.The issue appears to be linked to a product change that occurred over the summer, and the hospital is currently working with emr staff to retrieve the affected lot numbers.For further investigation and resolution, samples should be sent to: per follow up information received via email on 05nov2025, it was reported that the customer was not aware of specific harm, all 4 cases, that were brought to their attention, had their drains discontinued earlier than desired.No lot number was provided.

• 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: 23110187
• Report Number: 1018233-2025-08421
• Device Sequence Number: 9889697
• Product Code: GBX
• UDI-Device Identifier: 00801741090745
• UDI-Public: (01)00801741090745
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0070370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown