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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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BECTON, DICKINSON AND CO. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: (b)(6).Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd posiflush¿ pre-filled saline syringe was contaminated.The following information was provided by the initial reporter: as the syringe was about to be used on the ward, it was noticed that there was contamination floating in it.It was initially appeared to be blood but on closer inspection appears to be red string with dye leaking from it.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 29-nov-2022.H6: investigation summary: the affected physical sample were returned for evaluation by our quality engineer team.The syringe had been removed from the blister packaging with the stopper depressed to the 8ml mark.Upon examination of the syringe, red foreign matter was observed floating within the solution.Red foreign matter was also observed in the tip cap.As part of our investigation, we endeavored to remove the red foreign matter; however, when we tried to extract it from the saline with tweezers, it became clear that the foreign material was a viscous liquid itself.The material did not mix with the saline, but floated within it, giving a ¿string¿ like appearance as described in the correspondence.There is no such substance anywhere in the associated manufacturing processes and given that a similar red substance was also observed in the syringe tip cap, it indicates that the substance was present when the product was used a part of a flush.Based on the investigation conducted, it is concluded that given the physical nature of the foreign matter, it is more likely to have been introduced from the clinical environment than the manufacturing process.
 
Event Description
It was reported that the bd posiflush¿ pre-filled saline syringe was contaminated.The following information was provided by the initial reporter: as the syringe was about to be used on the ward, it was noticed that there was contamination floating in it.It was initially appeared to be blood but on closer inspection appears to be red string with dye leaking from it.
 
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Brand Name
BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer (Section G)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15859385
MDR Text Key304284093
Report Number9616657-2022-00044
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K161552
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 02/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306572
Device Lot Number2166764
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2022
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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