MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	309606
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
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 of the bd safety-lok bd disposable syringe with bd luer-lok tip that the syringes were leaking.The leakage seems to be occurring at the luer lock/hub.There were two occurrences.
Event or Problem Description
It was reported that during use of the bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip that the syringes were leaking.The leakage seems to be occurring at the luer lock/hub.There were two occurrences.
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination.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.

• Brand Name: BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8433397
• Report Number: 1213809-2019-00363
• Device Sequence Number: 2205713
• Product Code: FMI
• UDI-Device Identifier: 30382903096061
• UDI-Public: 30382903096061
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: 11/30/2023
• Device Catalogue Number: 309606
• Device Lot Number: 8340873
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/02/2019
• 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