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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306547
Device Problem Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2023
Event Type  malfunction  
Event Description
It was reported while using bd posiflush¿ normal saline syringe, in 10 ml syringe the plunger was difficult to move.This occurred 30 times.There was no report of patient impact.The following information was provided by the initial reporter: it is very difficult to depress the syringe.It seems to get stuck part way through.Several from this lot were used and the same.
 
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 306547 and lot number 2237672.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
 
Event Description
It was reported while using bd posiflush¿ normal saline syringe, in 10 ml syringe the plunger was difficult to move.This occurred 30 times.There was no report of patient impact.The following information was provided by the initial reporter: it is very difficult to depress the syringe.It seems to get stuck part way through.Several from this lot were used and the same.
 
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Brand Name
BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
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 Key16357577
MDR Text Key309441093
Report Number1911916-2023-00066
Device Sequence Number1
Product Code NGT
UDI-Device Identifier00382903065479
UDI-Public(01)00382903065479
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K003553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306547
Device Lot Number2237672
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2022
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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