MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT EPIDURAL TRAY; 44TRAYS

Catalog Number 10-2815

Device Problem Shipping Damage or Problem (1570)

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

Event Type  malfunction  

Manufacturer Narrative

On 7/20/2016 integra investigation completed.Method: failure analysis, devices history evaluation.Results: failure analysis: the actual samples that were found to be broken and those that broke during use were not returned, however 18 kits from the same lot were returned and analyzed.All 18 kits were opened and inspected for damage that could indicate a root cause for the breaking glass syringes.During the inspection of the returned kits, only 1 glass syringe was found to have small cracking on the outer shaft of the syringe.The box used for shipping the glass syringes was also inspected for damage and damage along the sides was found.The cracked glass syringe was functionally tested for leaking using blue dye used for dye penetration leak testing per (b)(4) standards.No leaking was observed after multiple uses of the syringe.Slight hand force was applied to the male luer tip of the syringe and no further cracking or damage was observed.Devices history evaluation: the dhr was reviewed and no ncmr or other issue was found related to this complaint failure mode.Conclusion: the likely root cause for the damaged glass syringes is excessive mishandling during shipping.

Event Description

On (b)(6) 2016 customer reports correction.Doctor drew up lidocaine with no problem.When he injected the medication the syringe shattered.Procedure was a transforaminal epidural injection of steroids into a disc space.No open wound.No harm done.

• Brand Name: EPIDURAL TRAY
• Type of Device: 44TRAYS
• Manufacturer (Section D): INTEGRA PAIN MANAGEMENT; 3395 west 1820 south; 3395 west 1820 south; salt lake city UT 84104
• Manufacturer (Section G): INTEGRA PAIN MANAGEMENT; 3395 west 1820 south; salt lake city UT 84104
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5841650
• MDR Text Key: 52070528
• Report Number: 1722447-2016-00005
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10-2815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1