MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE

Catalog Number	309604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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 that 6 bd luer-lok¿ tip syringes had broken/damaged luer tips.The following information was provided by the initial reporter, translated from japanese: "damaged components".
Additional Manufacturer Narrative
H.6.Investigation summary: thirty five samples and photos received by our quality team for investigation.Through visual evaluation, foreign matter such as embedded particles, black dots, and ink stains observed on 12 syringes, 10 observed with incomplete marking scale, 6 with damaged barrel, jammed stopper on 3 syringes, and 4 with molding defect at the tip of syringe.A device history review was performed for lot 2045798, no deviations or non-conformances were identified during the manufacturing process that could have contributed to scale marking, damaged barrel, jammed stopper, and molding defect.Based on the quality teams investigation, the root cause for jammed stopper is misalignment of plunger-stopper-barrel in the assembly station, damaged barrel and molding defect is due to poor condition of conveyor belt, scale marking is due to ink level sensor, and foreign matter is embedded burnt material from molding process.This defect appeared due to the injection of burnt material generated during molding process.Before the injection machine is restarted up it is purged until the material is acceptable rejecting the first pieces.Injection machines are periodically subjected to maintenance and cleaning program.Manufacturing personnel have been notified and additional training to reinforce proper assembly has been performed.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.H3 other text : see h10.
Event or Problem Description
It was reported that 6 bd luer-lok¿ tip syringes had broken/damaged luer tips.The following information was provided by the initial reporter, translated from japanese: "damaged components".

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16529651
• Report Number: 9614033-2023-00020
• Device Sequence Number: 2645247
• Product Code: FMF
• UDI-Device Identifier: 00382903096046
• UDI-Public: 00382903096046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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 Catalogue Number: 309604
• Device Lot Number: 2045798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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