MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK TIP 10-ML SYRINGE; PISTON SYRINGE

Model Number 309604

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

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 Description

It was reported while using bd luer-lok tip 10-ml syringe the stopper was misaligned.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported multiple defects, including fm (dirt), printing issues, and damaged components, in a total of 35 products.

Event Description

It was reported while using bd luer-lok tip 10-ml syringe the stopper was misaligned.This occurred (b)(4) times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported multiple defects, including fm (dirt), printing issues, and damaged components, in a total of (b)(4) products.

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.

• Brand Name: BD LUER-LOK TIP 10-ML SYRINGE
• Type of Device: 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: 16512988
• MDR Text Key: 310983525
• Report Number: 9614033-2023-00016
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: (01)30382903096047
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 309604
• 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
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1