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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS ANTERIOR HIP PACK GENERAL SURGERY TRAY

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AMERICAN CONTRACT SYSTEMS ANTERIOR HIP PACK GENERAL SURGERY TRAY Back to Search Results
Model Number CDMH06C-01
Device Problems Contamination of Device Ingredient or Reagent (2901); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Date 10/02/2017
Event Type  Malfunction  
Event Description

Sterility of anterior hip surgical pack questioned and considered contaminated due to wood found within lap sponges located within the sterile surgical pack. Surgery cancelled by surgeon late in day. Outcome: 1. Delay of consumer service issue, for patient, patient's family, and physician. 2. Cost issue: all supplies had to be wasted and all instrumentation had to be reprocessed / resterilized.

 
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Brand NameANTERIOR HIP PACK
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
AMERICAN CONTRACT SYSTEMS
7802 e telecom pkwy
tampa FL 33637
MDR Report Key6961099
MDR Text Key89707321
Report Number6961099
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2017
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCDMH06C-01
Device LOT Number867171
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2017
Event Location Hospital
Date Report TO Manufacturer10/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/19/2017 Patient Sequence Number: 1
Treatment
NOT APPLICABLE.
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