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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE FLUSH SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE FLUSH SYRINGE Back to Search Results
Catalog Number 306595
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 2 10 ml bd posiflush¿ normal saline syringes experienced difficult plunger movement.The following information was provided by the initial reporter: the nurses in the department use flush to unpack and unlock the flushing tube and cannot move, nor can it pull back.
 
Event Description
It was reported that 2 10 ml bd posiflush¿ normal saline syringes experienced difficult plunger movement.The following information was provided by the initial reporter: the nurses in the department use flush to unpack and unlock the flushing tube and cannot move, nor can it pull back.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/27/2020.H.6.Investigation: a device history record review was performed for provided lot number 14501.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, 2 samples were received.They came with no packaging flow wrap and both samples came with the plunger rod-rubber stopper at 3.5ml of the scale.Both were tested for sustaining force and were within specification and a cause for the reported incident could not be determined.
 
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Brand Name
10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
Type of Device
SALINE FLUSH SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key10827159
MDR Text Key219185480
Report Number1911916-2020-01024
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2023
Device Catalogue Number306595
Device Lot Number0014501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Initial Date Manufacturer Received 10/18/2020
Initial Date FDA Received11/12/2020
Supplement Dates Manufacturer Received11/13/2020
Supplement Dates FDA Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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