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

Model Number 0070370

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

It was reported that the holes in the front and back of the flat drain tube were misaligned.As per follow-up information received on 07-dec-2021, no other damage was found.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The product had caused the reported failure.Visual evaluation of the returned sample noted one unopened (with original packaging), hubless drain.A potential root cause for this failure could be ¿incorrect set-up".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "indications for use: wound drains are used to remove exudates from wound sites.Contraindications: do not use for chest drainage.Warning: do not bypass/inactivate anti-reflux valve." the actual/suspected device was evaluated.

Event Description

It was reported that the holes in the front and back of the flat drain tube were misaligned.As per follow-up information received on 07dec2021, no other damage was found.

• Brand Name: SILICONE FLAT DRAIN
• Type of Device: SILICONE FLAT DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13051519
• MDR Text Key: 285462296
• Report Number: 1018233-2021-08250
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741090745
• UDI-Public: (01)00801741090745
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0070370
• Device Catalogue Number: 0070370
• Device Lot Number: NGFS4564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other