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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AM2PAT HEPARIN 10U/ML 3ML IV FLUSH

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AM2PAT HEPARIN 10U/ML 3ML IV FLUSH Back to Search Results
Lot Number 05032414
Event Date 11/14/2005
Event Type  Malfunction  
Event Description

Found particles inside heparin 10u/ml solution.

 
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Brand NameHEPARIN 10U/ML 3ML IV FLUSH
Manufacturer (Section F)
AM2PAT
*
Manufacturer (Section D)
AM2PAT
*
Device Event Key650315
MDR Report Key660888
Event Key628657
Report NumberMW1037645
Device Sequence Number1
Product CodeFMF
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 11/15/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2005
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device EXPIRATION Date03/01/2006
Device LOT Number05032414
OTHER Device ID Number64054-3003-02
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Event Location Unknown
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 11/15/2005 Patient Sequence Number: 1
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