MAUDE Adverse Event Report: RAYNHAM 120CM OPEN END CATH W/BACTISEAL; NEURO

Catalog Number NS5524

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 that the hakim bactiseal catheter is supposed to have holes on the side of the catheter for fluid drainage in case of clogging, and when the catheter was opened it was clear that there were no holes on the side.No patient contact/injury reported and the event led to 5 minutes surgical delay.

Event Description

N/a.

Manufacturer Narrative

The catheter was returned for evaluation.Review of the history device records for lot 5028205 conformed to the specifications when released to stock failure analysis - the catheter was visually inspected; the drainage holes and markings specified on the label are not present on the catheter.The complaint was confirmed.The review of the retains samples of product code ns5524 batch 5028205 and ns0339 batch 5028206 confirmed a mix-up between these two lots that occured during impregnation process.A corrective action is in place to treat this issue.

• Brand Name: 120CM OPEN END CATH W/BACTISEAL
• Type of Device: NEURO
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11227574
• MDR Text Key: 241831950
• Report Number: 3013886523-2021-00046
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K031123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: NS5524
• Device Lot Number: 5028205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR