MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE; N/A

Catalog Number NL8501330

Device Problem Flushing Problem (1252)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number 2648988-2018-00005.

Event Description

This report is 2 of 2 complaints.A distributor reported that two pudenz flushing valves were used on (b)(6) 2017 during an unspecified procedure.It was reported that the flushing was wrong for both flushing valves and that less water was observed from both connecting parts.There was no patient contact or injury.There was a reported 1-hour delay in surgery time due to the product problem.Additional information indicated that there was no patient complications reported as a result of the surgical delay.

Manufacturer Narrative

Investigation was completed on 22feb2018: the documentation review of reported lot did not reveal any anomalies that could cause the reported condition.No event, ncr and/or rework was recorded for the mentioned lots; therefore, it is concluded that the lot complied with all in-process inspections and testing requirements as specified in the manufacturing shop order and related procedures.Two valves were received inside the same package.These were visually inspected and no visual defect was observed.A piece of catheter tubing was connected to the proximal side of the valve.Water was passed through the valve using a syringe.All bubbles were removed from the valve and catheter.Then the water was allowed to flow through the valves by force of gravity alone.Being a low pressure valve a noticeable slowing of flow should occur between 5-50 mm above the base of the valve.The valve with lot number 1163977 worked as expected: at first a fast flow was observed, and between 5-50mm above the base of the valve a noticeable flow slowdown was observed.The experiment was repeated several times and worked as expected each time.The reported condition could not be repeated on this valve and thus cannot confirm the report.

• Brand Name: PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7264972
• MDR Text Key: 100247424
• Report Number: 2648988-2018-00006
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K760502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: NL8501330
• Device Lot Number: 1163977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2016
• 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