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

Model Number	309626
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.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 slip tip syringe experienced the plunger not working.The following information was provided by the initial reporter: the plunger does not work well.
Event or Problem Description
It was reported that the bd¿ luer slip tip syringe experienced the plunger not working.The following information was provided by the initial reporter: the plunger does not work well.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval: yes.D.10.Returned to manufacturer on: 31-aug-2022.D.4.Medical device lot #: 2070981.D.4.Medical device expiration date: 28-feb-2027.H.4.Device manufacture date: 11-mar-2022.D.4.Medical device lot #: 2042951.D.4.Medical device expiration date: 31-jan-2027.H.4.Device manufacture date: 11-feb-2022.H.6.Investigation summary: fourteen samples from lot number 2042951 were provided to our quality team for investigation.All samples were visually evaluated under the 30x microscope.No damage, defective grind or hooks were observed.The bevels and etch were good.Five samples were observed to have difficult plunger rod movement.Each sample was then connected to a syringe with saline solution.All the samples expelled the solution with normal flow.Potential root cause for the insufficient silicone defect is associated with the assembly process.These conditions are occurring below their expected frequency so no corrective action is required at this time.A device history record review was completed for provided lot number 2042951.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD¿ LUER SLIP TIP SYRINGE
• 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: 15314985
• Report Number: 1213809-2022-00524
• Device Sequence Number: 6361462
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: 30382903096269
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/15/2022

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: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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: Female