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

Catalog Number	309604
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Other lot number includes 3233231 and other expiration date includes 2028-08-31.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.H.4.Other lot number device manufacture date is 2023-09-22.
Event or Problem Description
It was reported that the bd luer-lok had leakage at the luer connection.The following information was provided by the initial reporter translated from japanese to english: during liposuction surgery, customer connected a cannula (made by coleman) to this syringe and aspirated, but the fat would not aspirate.They suspected that the cause of the fat not aspirating was a leak in the connection, so they applied gel around the connection (to fill the leak part), and when they aspirated again, they are able to aspirate.Customer would like us to investigate the product for any leaks.
Additional Manufacturer Narrative
Forty-nine samples from material 309604 batch 3233231 and 2326607 received for investigation.Through visual inspection, luer is damage on one syringe.Functional testing is performed on samples received, leak occurred on 22 syringes.Lue diameter was measured, dimensions are out of specification.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 is associated with the mold temperature in the injection process.Manufacturing personnel will be notified and additional training to reinforce proper assembly will be performed.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-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: 20518907
• Report Number: 9614033-2024-00069
• Device Sequence Number: 18113101
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: (01)30382903096047(11)230315(17)271130(10)2326607
• 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): 02/05/2025

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: Health Professional
• Device Catalogue Number: 309604
• Device Lot Number: 2326607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 02/05/2025
• 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