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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL CUSTOM PACK SHUNT GENERAL SURGICAL TRAY

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CARDINAL HEALTH 200, LLC CARDINAL CUSTOM PACK SHUNT GENERAL SURGICAL TRAY Back to Search Results
Model Number PN24SHLC3
Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 10/12/2018
Event Type  Malfunction  
Event Description

Sterile pack custom pack - when opened, found to have hair in the packs. All open supplies discarded and room set back up, no adverse impact to the pts.

 
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Brand NameCARDINAL CUSTOM PACK SHUNT
Type of DeviceGENERAL SURGICAL TRAY
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
MDR Report Key7984713
MDR Text Key124662405
Report NumberMW5080713
Device Sequence Number0
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/18/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPN24SHLC3
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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