MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN.; PISTON SYRINGE

Model Number	309625
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to using the 1 ml bd slip tip syringe with attached needle 26 g x 3/8 in., that needle hub comes off with shield removal.The following information was provided by the initial reporter: stated that when he tries to remove the shield the needle hub comes off with it.
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evalution?: yes, d9: returned to manufacturer on: 09-may-2022 h6: investigation summary sixty-eight packaged 1ml syringes (p/n 309625) with needle from batch 9151836 samples were received.Each sample was tested for shield removal forces.Twenty-three samples were found to have shield removal forces beyond the maximum specification.The observed condition was non-conforming per product specification.Potential root cause for the tight shield 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 9151836 is considered in compliance with our product specification requirements.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.
Event or Problem Description
It was reported that prior to using the 1 ml bd slip tip syringe with attached needle 26 g x 3/8 in., that needle hub comes off with shield removal.The following information was provided by the initial reporter: stated that when he tries to remove the shield the needle hub comes off with it.

• Brand Name: 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN.
• 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: 14196932
• Report Number: 1213809-2022-00236
• Device Sequence Number: 4481735
• Product Code: FMF
• UDI-Device Identifier: 30382903096252
• UDI-Public: 30382903096252
• 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): 05/20/2022

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 Expiration Date: 05/31/2024
• Device Model Number: 309625
• Device Catalogue Number: 309625
• Device Lot Number: 9151836
• 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: 04/01/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2019
• 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