MAUDE Adverse Event Report: PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number 823832

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/16/2021

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 that during pre-testing before implantation, the physician found that there was water leaking from the needle chamber of a hakim valve.The procedure was completed with a replacement product.No patient injury reported, however, a 30 minute delay was noted.

Manufacturer Narrative

The hakim valve was returned for evaluation.Device history record (dhr) - the product code 823832 with lot 4266283 conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defects were noted.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.The catheter was irrigated no occlusions noted.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could not be determined as no leakage from the needle chamber was noted at the time of investigation.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH SG
• MDR Report Key: 12445571
• MDR Text Key: 270592943
• Report Number: 3013886523-2021-00384
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 823832
• Device Lot Number: 4266283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1