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

Catalog Number	309579
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.6.Investigation summary: one hundred fifty-eight samples were provided to our quality team for investigation.Through visual inspection, it was observed that syringes have an ink ring down by the flange outside the print area.The ink ring does not affect form, fit, or function of syringes.Additionally, four syringes have one ink dot which are acceptable per quality specification.Furthermore, two syringes have one large ink dot, two syringes have a cross-threaded needle attached to the syringe, one syringe has an insecure stopper on the end of the plunger, one syringe is missing print from the zero line to the 1/2ml area of the barrel, and one syringe has a broken needle hub.The conditions observed are non-conforming per product specification.Potential root cause for the ink ring, ink dots and missing print conditions are associated with the marking process.Potential root cause for the cross-thread needle, insecure stopper and broken needle hub defects are associated with the assembly process.These defects are occurring below an expected rate so no corrective actions will be made at this time.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided batch 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.H3: see h10.
Event or Problem Description
It was reported that the stopper on the bd luer-lok¿ syringe with precisionglide¿ needle plunger was loose.This complaint was created to capture the 2nd of 4 related incidents.The following information was provided by the initial reporter: "158 units have black substance on the syringe tube also black dots on the tubes.Please confirm if the foreign matter is on the outside of the syringe barrel or in the path of fluid.From what we can tell without opening the packages it appears to be on the outside of the barrel.".Via bd investigation team: "one hundred fifty-eight samples were provided to our quality team for investigation.Through visual inspection.One syringe has an insecure stopper on the end of the plunger".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ 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 ; 8448235433
• MDR Report Key: 16844044
• Report Number: 1213809-2023-00438
• Device Sequence Number: 6888811
• Product Code: FMF
• UDI-Device Identifier: 00382903095797
• UDI-Public: 00382903095797
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 04/27/2023

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: 309579
• Device Lot Number: 2158080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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