MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML LUER-LOK SYRINGE; PISTON SYRINGE

Model Number	309637
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use leakage is occurring at the connection site with a bd 1ml luer-lok¿ syringe.This occurred on 2 separate with the same patient.The following information was provided by the initial reporter: it was reported that the syringe was leaking at the luer lock connection site and it happened twice with the same patient.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident, therefore a root cause could not be determined.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.H3 other text : see section h.10.
Event or Problem Description
It was reported that during use leakage is occurring at the connection site with a bd 1ml luer-lok¿ syringe.This occurred on 2 separate with the same patient.The following information was provided by the initial reporter: it was reportedthat the syringe was leaking at the luer lock connection site and it happened twice with the same patient.

• Brand Name: BD 1ML LUER-LOK SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9411299
• Report Number: 1213809-2019-01214
• Device Sequence Number: 13590005
• Product Code: FMF
• UDI-Device Identifier: 30382903096375
• UDI-Public: 30382903096375
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: 309637
• Device Catalogue Number: 309637
• Device Lot Number: 9092890
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other