MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK

Catalog Number	309632
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Other lot number includes 3101292 and other expiration date includes 03/31/2028.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H.4.Other lot number device manufacture date is 04/11/2023.
Event or Problem Description
It was reported, that the bd luer-lok syringe had leakage.The following information was provided by the initial reporter: "it's hard to see but when the provider injects medication it comes out the side of the syringe.Speculating a hairline crack somewhere on the device.".
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) - follow up mdr for device evaluation.It was reported medication it comes out the side of the syringe.To aid in the investigation, one hundred seventy-three samples of 5m luer lok syringes from lots 3101292 and 3174004 were received for evaluation by our quality team.Ninety samples were from lot 3174004 and eighty-three samples were from lot 3101292.Each sample was visually inspected, and pressure tested for leakage.No samples were found to have any cracks or leakage.The samples returned are acceptable per product specification.A device history record review was completed for provided material number 309632, lots 3101292 and 3174004.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Lots 3101292 and 3174004 were inspected and accepted based on meeting our inspection control plan, subsequently approved for shipment and are considered in compliance with our product specification requirements.No corrective action is required at this time.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD LUER-LOK
• Common Device Name: BD LUER-LOK
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18156922
• Report Number: 1213809-2023-01283
• Device Sequence Number: 12379056
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: (01)30382903096320
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 309632
• Device Lot Number: 3174004
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown