MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 23 G; PISTON SYRINGE

Model Number	309589
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd luer-lok¿ syringe with attached needle 23 g scale markings were missing.This occurred 30 times.There was no report of patient impact.The following information was provided by the initial reporter: about 30 syringes from this box have no markings.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd luer-lok¿ syringe with attached needle 23 g scale markings were missing.This occurred 30 times.There was no report of patient impact.The following information was provided by the initial reporter: about 30 syringes from this box have no markings.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 07-feb-2023.H6: investigation summary: twenty-seven samples were provided to our quality team for investigation.Through visual inspection, it was observed that barrels were missing all its scale markings.Potential root cause for the missing print defect is associated with the marking process.A device history record review was completed for provided lot number 1008096.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 23 G
• 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: 16317088
• Report Number: 1213809-2023-00063
• Device Sequence Number: 8645819
• Product Code: FMF
• UDI-Device Identifier: 30382903095897
• UDI-Public: (01)30382903095897
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/17/2023

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 Expiration Date: 12/31/2025
• Device Model Number: 309589
• Device Catalogue Number: 309589
• Device Lot Number: 1008096
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• 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