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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOMED SUPPLIES, INC. THERASAFE SET, I.V. FLUID TRANSFER

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CARDIOMED SUPPLIES, INC. THERASAFE SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number CM-TS17X1B
Device Problems Defective Component (2292); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/26/2018
Event Type  Malfunction  
Event Description

Blood does not flow into the bag, even with manipulation. Some bags work and others do not. Defective product was thrown away due to open needle and contact with bodily fluids.

 
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Brand NameTHERASAFE
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
CARDIOMED SUPPLIES, INC.
15815 sw 11th ct. road
ocala FL 34473
MDR Report Key9244245
MDR Text Key163931137
Report Number9244245
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCM-TS17X1B
Device LOT Number021839-1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/16/2019
Event Location Hospital
Date Report TO Manufacturer10/28/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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