MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309604
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
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 luer was cracked/damaged/deformed.The following information was provided by the initial reporter translated from japanese to english: "it was reported that deformation of the syringe tip was observed during inspection at togo medikit (1 case).Seven other defective products were reported." 41 samples were returned.Bdj confirmed 1 luer deformed, 2 barrel deformed, 17 embedded fm/black spots, 2 stopper deformed and 19 scale marking blurred.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.The manufacturing plant was incorrect in the initial mdr.The manufacturing plant should be becton dickinson de mexico - cuautitlan, izcalli, mexico / 54730.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Forty one samples and nine photos received for investigation.Through visual inspection, poorly assembled stopper, damaged barrel, scale marking issue, damaged luer tip, embedded yellow stain on the flange, black spot on the outside of the barrel, and black stain on the tip of syringe are observed.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.Fourier transform infrared spectroscopy was performed to identify the black stain.The foreign substance was composed of ink.Based on the teams investigation, possible root cause for: -yellow stain is associated with resin from the molding process.Cleaning will be implemented.-black spot is associated with burnt material generating during the molding process and becoming injected into the syringe mold, embedding the burnt material as seen in the sample provided.-black ink stain is associated with excess ink during the marking process.-scale marking issue is associated with misalignment of the pads in marking process.-damaged barrel is associated with misalignment of the sensor.Correct positioning of the sensor will be implemented.-luer tip damage is associated by a hit or a jamming in assembly process.-poorly assembled stopper is associated with damage valve that does the silicone during the assembly of the plunger/stopper.Change of air valves will be executed.Manufacturing personnel will be notified and additional training to reinforce proper assembly will be performed.
Event or Problem Description
No additional information received.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18754067
• Report Number: 1213809-2024-00104
• Device Sequence Number: 17712249
• 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,Followup
• Report Date (Section B): 04/29/2024

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: 3108837
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024; 04/29/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 02/21/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown