MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR INTEGRA RESERVOIR 1.5CM DOME, FLAT BOTTOM, SIDE; N/A

Catalog Number NL8501214

Device Problems Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2017

Event Type  malfunction  

Event Description

A hair was contained in the package when checked by the distributor.There was no patient involvement.

Manufacturer Narrative

Investigation completed 6/19/2017.Method: -device history review; -trend analysis; -failure analysis.Review of device history record (dhr): device history record (dhr) for lot number 1165742 was reviewed.Lot number: 1165742; catalog number: nl8501214; device identifier: (b)(4); product identifier: (b)(4); mfg (pack) date: december 15, 2016; expiration date: december 31, 2021.No anomalies were found during manufacturing/packaging process of the product.Review of integra's complaint system from may 2015 to may 2017, there is no other complaint related to the reported condition for the shunt systems product family and accessories.(b)(4).One sample was returned; the foreign matter was visible inside the sealed product.When pouch was opened, it was confirmed that the particle was in the outside pouch (not in contact with the product).The particle was a dark, straight filament about 2 mm long and could be, as described by the customer, a hair.Therefore, the complaint is confirmed.Conclusion: this product is supplied in a sterile, non-pyrogenic, double-wrap packaging system.The double-wrap system facilitates the preferred method of sterile product transfer from the circulating area to the sterile field.Inside of the outer pouch there will be three (3) different components: an ifu, one (1) pouch containing the integra csf reservoir, and a second pouch containing the ventricular catheter and stylet.The hair was between the inner components and outer pouch (not in direct contact with the product).

• Brand Name: INTEGRA RESERVOIR 1.5CM DOME, FLAT BOTTOM, SIDE
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6610531
• MDR Text Key: 76864346
• Report Number: 2648988-2017-00018
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NL8501214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

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: Other
• Device Catalogue Number: NL8501214
• Device Lot Number: 1165742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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