MAUDE Adverse Event Report: SALT LAKE CITY UNIVERSAL BLOCK TRAY; 44TRAYS

Catalog Number 13-2890

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The device history record was review and there were no non-conformances or other issue found related to the complaint failure mode for lot w1809006.The root cause cannot be determined due to the product was not returned.The reported complaint was not confirmed.Linked to mfg report number: 1722447-2019-00002.

Event Description

This is 1 of 2 reports.A senior inventory analyst reported that the medicine cup included in the 13-2890 universal block tray, have tiny black particles in them and ¿two patients got infection due to contamination¿.Additional information was received on (b)(6) 2019 indicating that the incident happened on (b)(6) 2019.The patient was prepped for surgery and it is unknown if there was surgery delay.The product problem was discovered before, during and after an unspecified procedure.Request for additional information has been sent, but no other clinical information has been provided.

• Brand Name: UNIVERSAL BLOCK TRAY
• Type of Device: 44TRAYS
• Manufacturer (Section D): SALT LAKE CITY; 1900 south 4490 west; 1900 south 4490 west; salt lake city UT 84104
• Manufacturer (Section G): SALT LAKE CITY; 1900 south 4490 west; salt lake city UT 84104
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8386833
• MDR Text Key: 137718294
• Report Number: 1722447-2019-00001
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K960100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 13-2890
• Device Lot Number: W1809006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• 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