MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL

Catalog Number 302113

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.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 leakage occurred during use with a syringe 3ml ll.The following information was provided by the initial reporter, "drug leak from syringe barrel.What is drug being leaked? customer said ¿vincristine sulfate 1mg.¿ was customer exposed to blood / bodily fluids? no, it was.Was customer wearing personal protective equipment (ppe) such as gloves, eye mask? hospital guidelines suggest wearing protective things during preparation.".

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.

Event Description

It was reported that leakage occurred during use with a syringe 3ml ll.The following information was provided by the initial reporter."drug leak from syringe barrel 1.What is drug being leaked? - customer said ¿vincristine sulfate 1mg¿.2.Was customer exposed to blood / bodily fluids? - no, it was.3.Was customer wearing personal protective equipment (ppe) such as gloves, eye mask? -hospital guidelines suggest wearing protective things during preparation.".

• Brand Name: SYRINGE 3ML LL
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9526817
• MDR Text Key: 179132395
• Report Number: 8041187-2019-01034
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302113
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other