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	11/17/2023
Type of Reportable Event	Malfunction
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 the bd luer-lok syringe had foreign matter.The following information was provided by the initial reporter translated from japanese to english: "ink adheres to the tip of the syringe.Ink adhesion was confirmed on about 1/10 of this lot at the time of receiving inspection.".
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Samples and photos received for investigation.Through visual inspection, black foreign matter is observed on the tip of the syringe.Further evaluation was conducted, the foreign matter is identified as ink.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.Possible root cause of the non-conformance can be related with failures in marking process, specifically, the ink spots were caused by broken silk pads.Manufacturing personnel have been notified and additional training to reinforce proper assembly has been performed.

• 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: 18298464
• Report Number: 9614033-2023-00143
• Device Sequence Number: 18022627
• 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): 03/25/2024

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 Catalogue Number: 309604
• Device Lot Number: 2269976
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 12/10/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown