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

Catalog Number	309577
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd luer-lok syringe was damaged.The following information was provided by the initial reporter: "while doing a procedure, one of the syringes snapped in half." physician continued procedure using another syringe.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) - follow up mdr for device evaluation.It was reported one of the syringes snapped in half.To aid in the investigation, eleven samples of 3ml luer lok syringes from lot 3003985 were received for evaluation by our quality team.Ten of the samples were in sealed packaging blisters with all applicable product information on the top web.There were no defects observed on these ten samples.One sample was received loose and has a crack in the barrel extending 1 1/8" from the zero line down towards the 2ml 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 309577, lot 3003985.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Lot 3003985 was inspected and accepted based on meeting our inspection control plan, subsequently approved for shipment and is considered in compliance with our product specification requirements.This condition is occurring at or below its expected frequency; therefore, 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: 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18027025
• Report Number: 1213809-2023-01191
• Device Sequence Number: 20722227
• Product Code: FMF
• UDI-Device Identifier: 30382903095774
• UDI-Public: (01)30382903095774
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2024

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: Health Professional
• Device Catalogue Number: 309577
• Device Lot Number: 3003985
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 02/03/2024
• Initial Report FDA Received Date: 10/29/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown