MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Model Number	309626
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
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 prior to use with 2 bd¿ luer slip tip syringe with attached needle foreign matter was discovered on the needle.The following information was provided by the initial reporter: needles for injections at home but they are dirty.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 22-mar-2023.H6: investigation summary two sealed samples were provided to our quality team for investigation.Through visual inspection, a greyish-brown particulate foreign matter in non-fluid path was observed.Potential root cause for the foreign matter in non-fluid path defect is associated with the assembly process.A device history record review was completed for provided lot number 2131730.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
It was reported that prior to use with 2 bd¿ luer slip tip syringe with attached needle foreign matter was discovered on the needle.The following information was provided by the initial reporter: needles for injections at home but they are dirty.

• Brand Name: BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED 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: 16464219
• Report Number: 1213809-2023-00130
• Device Sequence Number: 19412250
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: (01)30382903096269
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: Lay User/Patient
• Device Model Number: 309626
• Device Catalogue Number: 309626
• Device Lot Number: 2131730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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