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

Catalog Number	309604
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd luer-lok had foreign matter.The following information was provided by the initial reporter translated from japanese to english: it was reported that during the inspection of the products at togo medikit, smear/missing scale, dirt, dislodged gasket, damage, burr were detected before use.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that during the inspection of the products at togo medikit, smear/missing scale, dirt, dislodged gasket, damage, burr were detected before use.
Additional Manufacturer Narrative
Thirty six samples and photos received by our quality team for investigation.Through visual inspection, it is observed the stopper is poorly assembled, flange of barrel is damaged, black stain in non-fluid path, incomplete scale marking, and tip of syringe has a burr.Fourier transform infrared spectroscopy was performed to further analyze the black stain.The foreign substance was mainly composed of ink, a component used during manufacturing of the product to mark the scale.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Possible root cause for poorly assembled stopper is associated with damaged air valves, a change of the valves will be implemented.For damaged barrel is associated with sensor detection, sensor will be reviewed and corrected.Burr on tip is associated with conveyor belt in poor condition, the production line of the conveyor belt will be changed.Ink stain is associated with the marking machine due to a misalignment of the cutter and the inkpot causing the incorrect marking.Incomplete scale marking is associated with failure in the patterns that transfers the scale.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
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20337171
• Report Number: 9614033-2024-00065
• Device Sequence Number: 15860174
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: (01)30382903096047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown