MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK 3ML W/NDL; PISTON SYRINGE

Model Number	309579
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
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 there were scale marking issues with 2 bd luer-lok¿ 3ml w/ndl.The following information was provided by the initial reporter: 3ml bd luer lock syringes that had issues with markings.One has no markings and the other has markings that are not legible.
Additional Manufacturer Narrative
H.6.Investigation: two photos and two sealed packaged syringes from batch 1022131 (p/n 309579) were received and visually evaluated.One syringe was observed to have no print whatsoever.Another syringe had both a severe skewed scale and parts of the print missing and/or illegible.Potential root cause for the missing and skewed print defects are associated with the marking process.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that there were scale marking issues with 2 bd luer-lok¿ 3ml w/ndl.The following information was provided by the initial reporter: 3ml bd luer lock syringes that had issues with markings.One has no markings and the other has markings that are not legible.

• Brand Name: BD LUER-LOK 3ML W/NDL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11825703
• Report Number: 1213809-2021-00324
• Device Sequence Number: 3724867
• Product Code: FMF
• UDI-Device Identifier: 30382903095798
• UDI-Public: 30382903095798
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/17/2021

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: 309579
• Device Catalogue Number: 309579
• Device Lot Number: 1022131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1