BD? SYRINGE WITH BD LUER-LOK? TIP 309653

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-19 for BD? SYRINGE WITH BD LUER-LOK? TIP 309653 manufactured by Becton Dickinson And Company.

Event Text Entries

[186322833] Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: 27 samples were received. They came in sealed packaging blister. Visual inspection was performed. They all have the barrel damaged at the 35ml mark area. When the barrel got damaged the plunger rod got damaged too. After the molding process the barrel goes for printing the scale then silicone is applied; after that the plunger-rubber stopper is assembled. A jam could have occurred during the assembly process and the damages were not detected in the next processes. 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: this is the 1st complaint for lot # 9275467 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of these batch #s. Root cause description: root cause_ syringe assembly process. After the molding process the barrel goes for printing the scale then silicone is applied; after that the plunger-rubber stopper is assembled. A jam could have occurred during the assembly process and the damages were not detected in the next processes.
Patient Sequence No: 1, Text Type: N, H10


[186323014] It was reported that a cracked barrel was found before use with a bd? Syringe with bd luer-lok? Tip. The following information was provided by the initial reporter, "caller wishing to report quality issue with product# 309653, lot# unknown at this time (60ml luer-lok syringe). Caller states she has quantity of 25+ syringes that have defective barrels and plungers. Per phone conversation on 3/6/2020: customer stated that the barrels are cracked and when pulling plunger back pieces are broken off. Has samples to return. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1911916-2020-00273
MDR Report Key9856974
Report SourceOTHER,USER FACILITY
Date Received2020-03-19
Date of Report2020-03-06
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-10-02
Date Added to Maude2020-03-19
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 G1BECTON DICKINSON AND COMPANY
Manufacturer Street2153 12TH AVENUE
Manufacturer CityCOLUMBUS NE 68601
Manufacturer CountryUS
Manufacturer Postal Code68601
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD? SYRINGE WITH BD LUER-LOK? TIP
Generic NamePISTON SYRINGE
Product CodeFMF
Date Received2020-03-19
Returned To Mfg2020-03-16
Model Number309653
Catalog Number309653
Lot Number9275467
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON AND COMPANY
Manufacturer Address2153 12TH AVENUE COLUMBUS NE 68601 US 68601


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.