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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, 500 USP UNITS/5ML; VASCULAR CATHETER FLUSH SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, 500 USP UNITS/5ML; VASCULAR CATHETER FLUSH SYRINGE Back to Search Results
Model Number 306424
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2022
Event Type  malfunction  
Event Description
It was reported that two 5 ml bd posiflush¿ heparin lock flush syringe, 500 usp units/5ml does not have the manufacturer label.The following information was provided by the initial reporter: patient received a sealed box of heparin 100u/ml flushes wherein 2 flushes had not manufacturer label.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The initial reporter also notified the fda on 05 may, 2022.Medwatch report # mw5109587.
 
Manufacturer Narrative
This complaint has been determined to be a duplicate of mfr report# 1911916-2022-00276.The original submission, 1911916-2022-00311 can therefore be disregarded.
 
Event Description
It was reported that two 5 ml bd posiflush¿ heparin lock flush syringe, 500 usp units/5ml does not have the manufacturer label.The following information was provided by the initial reporter: patient received a sealed box of heparin 100u/ml flushes wherein 2 flushes had not manufacturer label.
 
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Brand Name
5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, 500 USP UNITS/5ML
Type of Device
VASCULAR CATHETER FLUSH SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14776761
MDR Text Key294530127
Report Number1911916-2022-00311
Device Sequence Number1
Product Code NZW
UDI-Device Identifier30382903064244
UDI-Public30382903064244
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K090680
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/30/2023
Device Model Number306424
Device Catalogue Number306424
Device Lot Number131596N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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