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U.S. Department of Health and Human Services

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

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SALT LAKE CITY UNIVERSAL BLOCK TRAY 44TRAYS Back to Search Results
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 w1804187. The root cause cannot be determined due to the product was not returned. The reported complaint was not confirmed. Linked to mfg report number: 1722447-2019-00001.
 
Event Description
This is 2 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.
 
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Brand NameUNIVERSAL BLOCK TRAY
Type of Device44TRAYS
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 Key8384024
MDR Text Key137664702
Report Number1722447-2019-00002
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K960100
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 02/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number13-2890
Device Lot NumberW1804187
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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