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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIERRA PRE-FILLED INC. HEPARIN LOCK FLUSH SOLUTION, USP 10 UNITS/ML 3ML HEPARIN FLUSH SYRINGE

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SIERRA PRE-FILLED INC. HEPARIN LOCK FLUSH SOLUTION, USP 10 UNITS/ML 3ML HEPARIN FLUSH SYRINGE Back to Search Results
Lot Number 061222H
Event Type  Malfunction  
Event Description

White particulate matter of various sizes were found in multiple heparin lock flush solution syringes -ndc# 64054-303-02-. In some instances, the particles dissolved upon agitation of the solution. White sediment streaks were also seen on the inside of some syringes. Both the particles and streaks were seen in syringes from multiple lot numbers including lot# 061222h, lot# 061115h, and lot# 061102h.

 
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Brand NameHEPARIN LOCK FLUSH SOLUTION, USP 10 UNITS/ML 3ML
Type of DeviceHEPARIN FLUSH SYRINGE
Manufacturer (Section F)
SIERRA PRE-FILLED INC.
9400 ransdell road
suite 10
raleigh NC 27603
Manufacturer (Section D)
SIERRA PRE-FILLED INC.
9400 ransdell road
suite 10
raleigh NC 27603
Device Event Key839217
MDR Report Key853308
Event Key816005
Report NumberMW1042857
Device Sequence Number1
Product CodeNZW
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 05/01/2007
3 DeviceS WERE Involved in the Event:1 2 3 
1 Patient Was Involved in the Event
Date FDA Received05/01/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date12/31/2008
Device LOT Number061222H
OTHER Device ID Number64054-3003-02
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Home
Was The Report Sent To Manufacturer? Yes
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: 05/01/2007 Patient Sequence Number: 1
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