MAUDE Adverse Event Report: RAYNHAM CODMAN BEVD 1.9MM CAT SET; BACTISEAL EVD CATHETERS

Catalog Number 821749

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 03/20/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a leaking ventricular catheter.The codman bactiseal external ventricular drain (evd) was placed in a patient on (b)(6) 2021.During the procedure, the white tip of the device at the connecting point was leaking cerebral spinal fluid.The physician changed with another of the same device to complete the procedure.There was a one-hour delay in the procedure, but no adverse consequences due to the leaking catheter.

Manufacturer Narrative

The catheter was returned for evaluation.Device history record (dhr) - the product code 821749 with lot 4561688 conformed to the specifications when released to stock.Failure analysis - the returned devices were visually inspected; no defects were noted with the catheter.The red leur lock cap with the female connector were returned attached, these have been screwed together so tightly that it is not possible to separate them, white cloudy stress marks on the connectors were noted this is due to over tightening the two parts.The devices were leak tested, and no leaks noted.Root cause - no root cause could be determined for the issue reported by the customer as no leakage was noted with the returned devices.The root cause for the stress marks noted in the connectors is due to over tightening, as noted in the ifu finger tighten only.The possible root cause of the problem reported by the customer is probably due to users error by using atypical force when attaching the connectors.As noted in the ifu ¿finger tighten only when attaching devices¿.The reported incident was not duplicated.

• Brand Name: CODMAN BEVD 1.9MM CAT SET
• Type of Device: BACTISEAL EVD CATHETERS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 11701378
• MDR Text Key: 262979715
• Report Number: 3013886523-2021-00173
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K090348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 821749
• Device Lot Number: 4561688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1