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

Catalog Number	309575
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
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
Material: 309575 batch#: 4157116 it was reported that the bd luer-lok had leakage.The following information was provided by the initial reporter: verbatim: complaint received by phone call on (b)(6) 2024.Xxxx called in the complaint for the customer and will be reaching out to the customer for additional information.Customer purchased 3 boxes of syringes.When administering the medication, it shot into the nurse's face.Mckesson was unable to provide name of medication at this time.This only happened with the 1 occurrence, but customer stated they ordered 3 boxes of the same lot.Material: 309575.Lot: 4157116.Xxxx no injury or adverse event reported unable to provide event date at this time.Unknown if sample is available- please follow up at time of ack email.Additional information provided: 1.Can you share any physical sample or photo if available for investigation? if yes, please provide the address of the facility for us to ship the return label? photos attached.Customer did not open any more syringes, but said they did test a few to see if it happened with multiple and all had the same issue.A.Facility name and address: (b)(6).2.Could you please provide a further description of the issue? customer drew a vaccine in to the syringe, and when they went to administer it to the child, the vaccine shot back up in to the nurse¿s face rather than being injected in to the skin through the syringe.3.How many occurrences of the product.At least 3 syringes, and the customer ordered 3 boxes of the syringes so they are assuming all are affected and are not using.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Two photos were provided to our quality team for investigation.The first photo shows a syringe in a fully sealed package and second photo shows the box label contains all the appropriate information for a 3 ml ll syringe with needle.No defects were identified in the photos received.A physical sample is required for a more thorough evaluation.Furthermore, a device history record review was completed for provided lot number 4157116.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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.

• 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 MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20682861
• Report Number: 1213809-2024-00840
• Device Sequence Number: 20653370
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750(11)240605(17)290531(10)4157116
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 309575
• Device Lot Number: 4157116
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown