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

Catalog Number	0070430
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
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 on (b)(6) 2025, an original issue was escalated to (b)(6) supply chain re: bard product#: 0070430 - 7mm flat drain.This drain has a fragile part of the drain that can be easily pulled off.This was discovered by an ent surgeon prior to implantation.In (b)(6), a bard rep was onsite, reviewed the product and the offered other products.At that time, no issue was identified with the product.On (b)(6) 2025, this issue was again escalated.Due to the piece easily being removed, concern exists for a potential retained foreign body when the drain was pulled post operatively.On (b)(6), (b)(6) engaged with bard to obtain a different lot#.That was received on 08/01.On (b)(6), notification was sent to the operating room staff re: this concern.On 08/05/2025, bard rep onsite to review issue and identified the same issue existed on the other lot# brought in.Per the rep, that will be internally escalated within bard investigation and review.These drains were being pulled and returned to bard from (b)(6) health sites.
Event or Problem Description
It was reported that in april 2025, an original issue was escalated to (b)(6) supply chain re: bard product#: 0070430 - 7mm flat drain.This drain has a fragile part of the drain that can be easily pulled off.This was discovered by an ent surgeon prior to implantation.In (b)(6), a bard rep was onsite, reviewed the product and the offered other products.At that time, no issue was identified with the product.On 7/30/2025, this issue was again escalated.Due to the piece easily being removed, concern exists for a potential retained foreign body when the drain was pulled post operatively.On 07/30, (b)(6) engaged with bard to obtain a different lot#.That was received on 08/01.On 07/30, notification was sent to the operating room staff re: this concern.On 08/05/2025, bard rep onsite to review issue and identified the same issue existed on the other lot# brought in.Per the rep, that will be internally escalated within bard investigation and review.These drains were being pulled and returned to bard from (b)(6) health sites.Reference report: mw5174384.
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.The labeling is found to be adequate.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: d.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.

• 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: 23084132
• Report Number: 1018233-2025-08297
• Device Sequence Number: 9738709
• Product Code: GBX
• UDI-Device Identifier: 00801741090752
• UDI-Public: (01)00801741090752
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: 0070430
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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: Other
• Patient Sex: Unknown