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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH
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BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2022
Event Type  malfunction  
Event Description
It was reported while using bd¿ posiflush¿ saline xs 10 ml the plunger would not depress easily.There was no report of patient impact.The following information was provided by the initial reporter: during its use, the plunger of the syringe remained stuck.
 
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 07-apr-2022.H.6.Investigation: to aid in the investigation of this issue, one physical sample and four picture samples were returned for evaluation by our quality engineer team.The physical syringe had been removed from the blister package and had a different tip cap applied to it.The syringe was partially used with 5ml of solution remaining.When attempting to expel the remaining solution from the syringe, excessive pressure had to be applied.The plunger became restricted again with 2ml of solution remaining.Based on the investigation results, we were able to confirm the reported issue.A device history record review was completed for provided material number 306572 and lot number 1306797.The review detected one non-conformance during the production process related to dry barrels.There was an intermittent issue with dry barrels which was resolved at the time of occurrence.The product associated with the defect was held for inspection and all of the affected material identified was scrapped.
 
Event Description
It was reported while using bd¿ posiflush¿ saline xs 10 ml the plunger would not depress easily.There was no report of patient impact.The following information was provided by the initial reporter: during its use, the plunger of the syringe remained stuck.
 
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Brand Name
BD¿ POSIFLUSH¿ SALINE XS 10 ML
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 Key13640547
MDR Text Key286594140
Report Number9616657-2022-00006
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 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306572
Device Lot Number1306797
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2021
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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