MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE; PISTON SYRINGE

Model Number	309631
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one photo and twelve 5ml syringes in fully sealed blister packs were received and evaluated.It was observed all the syringes had some degree of missing print.Five of the syringes had minimal to no print above the 4ml marking.Four of the syringes had large portions missing or no print between the 4ml and 1ml marking.Three of the syringes had most of the scale present with small areas of grad lines and/or numerical markings missing.All the syringes had a rejectable amount of missing print per product specification.Potential root cause for the missing print defect is associated with the marking process.No corrective actions are necessary based on the defective rate identified.Batch 0279279 is considered in compliance with our product specification requirements.Furthermore, 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported while using 6 bd luer-lok¿ syringe the scale marking were discovered to be missing.There was no report of patient impact.The following information was provided by the initial reporter: it was reported markings on syringe are missing.

• Brand Name: BD LUER-LOK SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11681890
• Report Number: 1213809-2021-00242
• Device Sequence Number: 14509249
• Product Code: FMF
• UDI-Device Identifier: 30382903096313
• UDI-Public: 30382903096313
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 04/08/2021

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: 09/30/2025
• Device Model Number: 309631
• Device Catalogue Number: 309631
• Device Lot Number: 0279279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1