MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOCK¿ SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number	309632
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
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 bd luer-lock¿ syringe with needle leaked and a crack was found in the barrel.The following information was provided by the initial reporter: "we have received a complaint from one of our customers stating that a bd syringe they received a dose in was leaking.The syringe was returned to the pharmacy and a crack on the side of the syringe was found.Date of event was (b)(6) 2022.The procedure was able to be completed although some product was lost due to the leak.We are not aware of any adverse effects on the patient.The syringe was disposed of as medical waste because the syringe is biohazardous waste.".
Additional Manufacturer Narrative
It was reported a crack was found on the side of the syringe.To aid in the investigation, one photo of a 5ml luer-lok syringe was received for evaluation by our quality team.The photo shows a loose 5ml syringe with a crack in the scale marking area of the barrel extending from the zero line to the 3ml graduation line.The condition observed is non-conforming per product specification and is associated with the assembly process.A device history record review was completed for provided material number 309632, lot number 2074969.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 2074969 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.These conditions appear to be occurring at or below their expected frequency.Batch 2074969 is considered in compliance with our product specification requirements.We appreciate you taking the time to bring this matter to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD LUER-LOCK¿ SYRINGE WITH NEEDLE
• Common Device Name: PISTON SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15965181
• Report Number: 1213809-2022-01222
• Device Sequence Number: 17536331
• Product Code: FMF
• UDI-Device Identifier: 50382903096324
• UDI-Public: 00382903096329
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 2074969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown