MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN, 10FR., HUBLESS FULL FLUTE WITH TROCAR; SILICONE CHANNEL DRAIN

Catalog Number 072227

Device Problems Fitting Problem (2183); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the channel drain was not as secured to the hub needle as it used to be, which caused it to fall off the introducer during insertion into the wound prior it being dislodged when warranted.

Event Description

It was reported that the channel drain was not as secured to the hub needle as it used to be, which caused it to fall off the introducer during insertion into the wound prior it being dislodged when warranted.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.A potential failure mode could be ¿trocar cannot be attached to tubing¿ with a potential root cause of ¿id of drainage tubing too small¿.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: "if an air-tigh seal between the drain and the skin where the drain emerges is not achieved, the air leak must be rectified or the system must be converted to open drainage.An airtight seal between all system components (drain, adaptor and reservoir) is necessary for proper system function.".

• Brand Name: CHANNEL DRAIN, 10FR., HUBLESS FULL FLUTE WITH TROCAR
• Type of Device: SILICONE CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8453919
• MDR Text Key: 140124266
• Report Number: 1018233-2019-01557
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741049873
• UDI-Public: (01)00801741049873
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 072227
• Device Lot Number: NGCW3566
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1