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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 SYRINGES,; SALINE, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGES,; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306546
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/21/2022
Event Type  malfunction  
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.
 
Event Description
It was reported while using bd posiflush¿ normal saline syringes the plunger movement was difficult.There was no report of patient impact.The following information was provided by the initial reporter: we found another of these syringes with problem.It is a different lot (2227032).
 
Manufacturer Narrative
H6: investigation summary: a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 2227032.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.H3 other text : see h10.
 
Event Description
It was reported while using bd posiflush¿ normal saline syringes the plunger movement was difficult.There was no report of patient impact.The following information was provided by the initial reporter: we found another of these syringes with problem.It is a different lot (2227032).
 
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Brand Name
BD POSIFLUSH¿ NORMAL SALINE SYRINGES,
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 Key15966171
MDR Text Key308028468
Report Number1911916-2022-00727
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065463
UDI-Public(01)30382903065463
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number306546
Device Catalogue Number306546
Device Lot Number2227032
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2022
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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