BD POSIFLUSH? SYRINGE 306594

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-14 for BD POSIFLUSH? SYRINGE 306594 manufactured by Bd Medical (bd West) Medical Surgical.

Event Text Entries

[187056259] Investigation summary: no samples or photos were received; therefore, sample analysis could not be performed and the condition reported by the customer could not be confirmed. While a definitive root cause could not be determined, it is possible that a jam occurred at the plunger rod assembly process inducing damages to the barrel. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. A device history record review was completed with zero defects found. No quality notifications were written for this batch, nor for the associated assembly batches. Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure as no samples or photos were returned. This is the 1st complaint for lot # 9140782 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of this batch. Root cause description: while a definitive root cause could not be determined, it is possible that a jam occurred at the plunger rod assembly process inducing damages to the barrel. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10


[187056260] It was reported that after finishing the patient's infusion, the handle of the bd posiflush? Syringe's barrel was found damaged before using it to seal the tube. The following information was provided by the initial reporter, translated from chinese to english: after the infusion for patient was finished on 11:30, 2020-03-05, the handle of the syringe' s barrel was damaged before the using of the prefilled catheter irrigator to seal the tube, it didn't use on the child, and there was no harmful effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1911916-2020-00247
MDR Report Key9832601
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-14
Date of Report2020-03-06
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-05-20
Date Added to Maude2020-03-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBDX BRETT WILKO
Manufacturer Street9450 SOUTH STATE STREET
Manufacturer CitySANDY UT 84070
Manufacturer CountryUS
Manufacturer Postal84070
Manufacturer Phone8015652341
Manufacturer G1BD MEDICAL (BD WEST) MEDICAL SURGICAL
Manufacturer Street1852 10TH AVENUE
Manufacturer CityCOLUMBUS NE 68601
Manufacturer CountryUS
Manufacturer Postal Code68601
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD POSIFLUSH? SYRINGE
Generic NameSALINE VASCULAR ACCESS FLUSH
Product CodeNGT
Date Received2020-03-14
Catalog Number306594
Lot Number9140782
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBD MEDICAL (BD WEST) MEDICAL SURGICAL
Manufacturer Address1852 10TH AVENUE COLUMBUS NE 68601 US 68601


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-14

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