MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 5ML SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Model Number 309649

Device Problem Leak/Splash (1354)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Two photos showing 5ml syringes in bags (p/n 309649).In one photo it was observed that a label had been placed on the syringe and the tip had been capped.Approximately 1ml of an unknown medication was also present in the syringe it was unclear in this photo if any leakage was occurring.Another photo displayed an identical scenario to the first photo except it appeared that medication had leaked past the back rib of the stopper which is a non-conforming condition per product specification.A physical sample that clearly displays the defect is required for a more thorough evaluation, leakage testing, and potential root cause determination.Since root cause could not be defined, corrective actions are not necessary at this time.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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.

Event Description

It was reported that the bd 5ml syringe luer-lok¿ tip experienced leakage past the plunger.The following information was provided by the initial reporter: we¿ve recently had a couple of syringes that have leaked from the black bung at the bottom of the syringe as the drug was administered and the plunger pushed into the barrel.

Event Description

It was reported that the bd 5ml syringe luer-lok¿ tip experienced leakage past the plunger.The following information was provided by the initial reporter: we¿ve recently had a couple of syringes that have leaked from the black bung at the bottom of the syringe as the drug was administered and the plunger pushed into the barrel.

Manufacturer Narrative

The following information has been updated/corrected: h.6.Imdrf annex e code: e2401.H.6.Imdrf annex f code: f1004.

• Brand Name: BD 5ML SYRINGE LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13101728
• MDR Text Key: 285365710
• Report Number: 1213809-2021-00826
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096498
• UDI-Public: 30382903096498
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309649
• Device Catalogue Number: 309649
• Device Lot Number: 0213251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1