MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE; SYRINGE AND NEEDLE

Catalog Number	309598
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2018
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 the customer had 2 cases of bd luer-lok¿ syringes with attached needles with leakage.There was no report of exposure, serious injury, or medical intervention.
Additional Manufacturer Narrative
15 loose 3ml syringes with needles attached and 1 opened empty blisterpack were received inside a zip lock bag.The blisterpack was from batch #8092918 (p/n 309598).The samples were visually evaluated through the bag.Some of the needles appeared loosely attached while others were almost flush the luer collar.No visual defects were observed.No additional evaluation could be performed due to potentially contaminated nature of the samples.No tests could be performed due to the risk of handling the potentially contaminated samples.No representative sealed samples from the 2 reported boxes of the same lot were returned for evaluation and testing.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.The reported defect was not identified in the samples received.
Event or Problem Description
It was reported that the customer had 2 cases of bd luer-lok syringes with attached needles with leakage.There was no report of exposure, serious injury, or medical intervention.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8057079
• Report Number: 1213809-2018-00756
• Device Sequence Number: 11321161
• Product Code: FMF
• UDI-Device Identifier: 30382903095989
• UDI-Public: 30382903095989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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: 03/31/2023
• Device Catalogue Number: 309598
• Device Lot Number: 8092918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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