MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN, 1 ML; PISTON SYRINGE

Model Number	309597
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
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 slip tip syringe with attached needle 26 g x 5/8 in, 1 ml there were scale marking issues.There was no report of patient impact.The following information was provided by the initial reporter: pt stated that 1 dosing syringe did not have numbers to measure volume on it.
Additional Manufacturer Narrative
One photo was provided to our quality team for investigation.Through visual inspection, it was observed that the barrel is missing most of its scale markings.Potential root cause for the scale marking defect is associated with the marking process.These defects are occurring below an expected rate so no corrective actions will be made at this time.These defects are occurring below an expected rate so no corrective actions will be made at this time.Furthermore, a device history record review was completed for provided lot numbers 2172095 and 2131738.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.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
No additional information.

• Brand Name: BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN, 1 ML
• 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 ; 8448235433
• MDR Report Key: 16519368
• Report Number: 1213809-2023-00168
• Device Sequence Number: 12399090
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: (01)30382903095972
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 309597
• Device Catalogue Number: 309597
• Device Lot Number: 2172095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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