MAUDE Adverse Event Report: BD LUER-LOK¿ SYRINGE WITH NEEDLE; PISTON SYRINGE

Model Number	309569
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The original date received by manufacturer has been used for this field.Investigation summary: one loose 3ml syringe (p/n (b)(4) with needle was received.The sample was visually evaluated.The needle was observed to be severely cross threaded onto the collar of the syringe.The observed condition was non-conforming per product specification.Potential root cause for the cross threading defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1076700 is considered in compliance with our product specification requirements.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.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.
Event or Problem Description
It was reported that the bd luer-lok¿ syringe with needle had issues with the needle separating from the syringe.The following information was provided by the initial reporter: "the needles are not straight." via bd investigation: "the needle was observed to be severely cross threaded onto the collar of the syringe.".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH NEEDLE
• Common Device Name: PISTON SYRINGE
• MDR Report Key: 12748835
• Report Number: 1213809-2021-00742
• Device Sequence Number: 4713520
• Product Code: FMF
• UDI-Device Identifier: 30382903095699
• UDI-Public: 30382903095699
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 309569
• Device Catalogue Number: 309569
• Device Lot Number: 1076700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2021
• 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