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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH
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BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Short Fill (1575)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2020
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 the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was only pre-filled halfway.The following information was provided by the initial reporter: "we have received a complaint in relation to product posiflush prefilled syringe, product code bd 306572, lot number 0008212.The customer states that the posiflush prefilled syringe in relation to it being half filled when trying to expel the air before flushing the line.".
 
Manufacturer Narrative
H6 investigation: a device history record review was completed for provided lot number 0008212.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 neither physical samples nor pictures were available for return, a thorough sample investigation could not be completed.Based on the limited investigation results, an exact cause could not be determined for this incident.H3 other text: see h10.
 
Event Description
It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was only pre-filled halfway.The following information was provided by the initial reporter: "we have received a complaint in relation to product posiflush prefilled syringe, product code bd 306572, lot number 0008212.The customer states that the posiflush prefilled syringe in relation to it being half filled when trying to expel the air before flushing the line.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/6/2021.H.6.Investigation: a device history record review was completed for provided lot number 0008212.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.To aid in the investigation of this incident, the affected sample was returned for evaluation by our quality engineer team.The sample was received without the original packaging and the plunger was already pressed down to the 8ml marking.The syringe¿s luer component and tip cap were inspected and no defects or leaks were identified.Based on the investigative results, an exact cause related to the manufacturing process could not be determined for this incident.
 
Event Description
It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was only pre-filled halfway.The following information was provided by the initial reporter: "we have received a complaint in relation to product posiflush prefilled syringe, product code bd 306572, lot number 0008212.The customer states that the posiflush prefilled syringe in relation to it being half filled when trying to expel the air before flushing the line.".
 
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Brand Name
BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
Type of Device
SALINE VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key11023851
MDR Text Key229529331
Report Number9616657-2020-00176
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 foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 08/09/2021
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 Date12/31/2022
Device Catalogue Number306572
Device Lot Number0008212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Initial Date Manufacturer Received 11/19/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received01/15/2021
08/09/2021
Supplement Dates FDA Received01/22/2021
08/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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