MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LUMBAR CATHETER, CLOSED TIP; N/A

Catalog Number INS5010

Device Problems Detachment Of Device Component (1104); Crack (1135); Fracture (1260); Leak/Splash (1354)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Event Description

This is the first of two reports.Customer stated they have had two issues where catheters were sheared and cracked at the end of the catheter and csf was leaking out/exposed to the atmosphere.Each time the catheters were placed by different physicians.They were not using the strain relief tube at the end of the catheter where the drainage bag is connected.The first instance was not reported and the equipment was not saved.They customer has some pieces from the second catheter that was saved.Additional information has been requested.Linked to mfg.Report number: 2648988-2017-00036.

Manufacturer Narrative

Investigation complete (b)(6) 2017.No lumbar catheter, closed tip ins5010 lot number was provided and therefore no device history record was possible.Approximately (b)(4) external drainage product family units have been released for distribution since (b)(6) 2015 ¿ (b)(6) 2017, resulting in a complaint occurrence rate of approximately (b)(4).No unit was returned and therefore complaint could not be confirmed.

• Brand Name: HERMETIC LUMBAR CATHETER, CLOSED TIP
• 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: 6867981
• MDR Text Key: 86261859
• Report Number: 2648988-2017-00035
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K922936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS5010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other