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

Model Number	309635
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
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 2295 of the bd syringe with hypodermic needle precisionglide¿ experienced foreign matter.The following information was provided by the initial reporter: 2,295 units have black dots.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 10-mar-2023.H6: investigation summary: two thousand two hundred ninety-five samples were provided to our quality team for investigation.A visual inspection was performed, and no defects or imperfections were observed on two hundred sixty-two samples.One thousand nine hundred ninety-six samples were observed to have small ink dot on the barrel on the opposite side of the scale marking area.The conditions observed are acceptable per product specification.Thirty-two samples had six or more ink dots and five samples had one ink dot in the non-scale marking area.The conditions observed are non-conforming per product specification.Potential root cause for the ink dots defect is associated with the marking process.This defect is occurring below an expected rate so no corrective actions will be made at this time.A device history record review was completed for provided lot number 2102324.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 2295 of the bd syringe with hypodermic needle precisionglide¿ experienced foreign matter.The following information was provided by the initial reporter: (b)(4) units have black dots.

• Brand Name: BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿
• 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: 16415194
• Report Number: 1213809-2023-00105
• Device Sequence Number: 17578224
• Product Code: FMF
• UDI-Device Identifier: 30382903096351
• UDI-Public: (01)30382903096351
• 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,Followup
• Report Date (Section B): 03/14/2023

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 Model Number: 309635
• Device Catalogue Number: 309635
• Device Lot Number: 2102324
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• 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