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

Catalog Number 302995

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

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 drug leaked past the stopper/plunger while using bd luer-lok¿ syringe.No patient impact reported.The following information was provided by the initial reporter: pharmacy tech was withdrawing chemo from a vial using an optima injector and bd 10ml syringe.The drug started to leak from what appeared to be behind the syringe plunger.It did not appear to be leaking from the optima injector.The pharmacy tech believes they may have broken the seal around the plunger.

Event Description

It was reported that the drug leaked past the stopper/plunger while using bd luer-lok¿ syringe.No patient impact reported.The following information was provided by the initial reporter: pharmacy tech was withdrawing chemo from a vial using an optima injector and bd 10ml syringe.The drug started to leak from what appeared to be behind the syringe plunger.It did not appear to be leaking from the optima injector.The pharmacy tech believes they may have broken the seal around the plunger.

Manufacturer Narrative

H6: investigation summary: three photos were provided to our quality team for investigation.One photo displayed a biohazard bag with the lot, expiration and material number present.One photo displayed a vial of camptosar in a bag with the syringe (p/n 302995) plunger thumb rest present.A third photo displayed a 10ml customer capped syringe with approximately 5.5ml of medication present.No visible defects or leakage observed in the photo.A physical sample is necessary to perform leakage past stopper testing to verify presence of the defect.A device history record review was completed for provided lot number 1351242.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD LUER-LOK¿ SYRINGE
• 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: 14720877
• MDR Text Key: 301015483
• Report Number: 1213809-2022-00339
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: 00382903029952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302995
• Device Lot Number: 1351242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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