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

Catalog Number CUS290

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Two procedure trays found with hair inside.

Manufacturer Narrative

10/26/2015 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - the product could not be analyzed because it was not returned.Device history evaluation - the device history record was reviewed and the products met all specifications at the time of manufacture.Conclusion: a root cause analysis could not be performed because the device was not returned for evaluation.However, the root cause of the complaint would likely be due to gowning procedures not followed.

• Brand Name: PROCEDURAL TRAY
• Type of Device: 44 - TRAYS
• 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; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5093555
• MDR Text Key: 26650772
• Report Number: 1722447-2015-00011
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K935245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/02/2015

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: Health Professional
• Device Catalogue Number: CUS290
• Device Lot Number: W1505065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• 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