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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%; PREFILLED SALINE SYRINGE
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BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PREFILLED SALINE SYRINGE Back to Search Results
Catalog Number 306572
Device Problems Break (1069); Leak/Splash (1354); Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2021
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.
 
Event Description
It was reported that bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced a case of leakage, a case of air in syringe, and a case of a damaged syringe tip.The following information was provided by the initial reporter: infusion leaks on ktc.Air in the tubing.Screw thread bi-directional valve "auto-flush" (in central kt kit) broken.There was no consequence for the patient but there could have been some since air was found in the tubing.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: (b)(6) 2021.H6: investigation summary a device history record review was completed for provided lot number 1160335.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one syringe sample with open packaging was received for evaluation by our quality engineer team.Through examination of the sample, a small air bubble could be observed.However, the air bubble appeared to recede by slightly turning and gently prodding the syringe.This is the first report received for air bubbles on material 306572 & lot number 1160335.A third-party catheter accessory was attached to the syringe upon receipt.The syringe¿s luer component was tested and inspected for signs of damage, sink marks, luer angle, or any other potential defect.None of the inspections performed were able to confirm the reported incident in relation to the bd posiflush syringe.H3 other text : see h10.
 
Event Description
It was reported that bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced a case of leakage, a case of air in syringe, and a case of a damaged syringe tip.The following information was provided by the initial reporter: infusion leaks on ktc.Air in the tubing.Screw thread bi-directional valve "auto-flush" (in central kt kit) broken.There was no consequence for the patient but there could have been some since air was found in the tubing.
 
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Brand Name
BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
Type of Device
PREFILLED SALINE SYRINGE
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer (Section G)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12802533
MDR Text Key285344177
Report Number9616657-2021-00092
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306572
Device Lot Number1160335
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2021
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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