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

Catalog Number 3404882

Device Problems Leak/Splash (1354); Shipping Damage or Problem (1570)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer reports they had one tray where the 10ml 0.5% bupivacaine had leaked and the content had crystals in it.Doctor didn't catch it until after injecting it epidurally into the patient.There were no sequellac.Another vial of the same med had leaked.

Manufacturer Narrative

On (b)(4) 2016 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - a failure analysis cannot be completed without the return of the product and packaging.No trends in leaking bupivacaine have been identified as only 1 other complaint for broken bupivacaine has been reported in the past 7 years.Device history evaluation - the dhr was reviewed and no evidence of nonconforming product being used for manufacturing the lot was identified.Conclusion: a root cause analysis cannot be completed at this time since the defective product was not returned to integra pain management to be investigated.

• Brand Name: COMBINED SPINAL/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: 5438001
• MDR Text Key: 38857164
• Report Number: 1722447-2016-00002
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K943319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3404882
• Device Lot Number: W1510181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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