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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 5ML HEPARIN; HEPARIN, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 5ML HEPARIN; HEPARIN, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306424
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 07/10/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that patient admitted to hospital due to sever thrombosis after being treated with a bd syringe 5ml heparin.The following information was provided by the initial reporter: customer called and stated that a patient was treated with a bd posiflush ((b)(6) 2019) has been admitted to the hospital today ((b)(6) 2019) with severe thrombosis leukaemia.Pt's platelets yesterday were normal and as at time of admission is 2.Customer has isolated remaining products from this lot and has representative samples to send.
 
Event Description
It was reported that patient admitted to hospital due to sever thrombosis after being treated with a bd syringe 5ml heparin.The following information was provided by the initial reporter: customer called and stated that a patient was treated with a bd posiflush ((b)(6) 2019) has been admitted to the hospital today ((b)(6) 2019) with severe thrombosis leukaemia.Pt's platelets yesterday were normal and as at time of admission is 2.Customer has isolated remaining products from this lot and has representative samples to send.
 
Manufacturer Narrative
Investigation: five representative samples were received.They came in the sealed packaging flow wrap.They were sent to the laboratory for testing.Testing results were good and all sample passed.All our inspections and testing performed while manufacturing above listed batch were accepted.No rejections were documented.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
 
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Brand Name
BD SYRINGE 5ML HEPARIN
Type of Device
HEPARIN, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key8832803
MDR Text Key152499900
Report Number1911916-2019-00735
Device Sequence Number1
Product Code NZW
UDI-Device Identifier30382903064244
UDI-Public30382903064244
Combination Product (y/n)N
PMA/PMN Number
K090680
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2020
Device Catalogue Number306424
Device Lot Number836283N
Date Manufacturer Received07/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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