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

Catalog Number	309575
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Other lot number includes 4152464 and other expiration date includes 2029-05-31.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 2024-05-31.
Event or Problem Description
Materials: 309575, batch#: 4152464,4184699.It was reported that the bd luer-lok has a syringe needle connectivity issue.The following information was provided by the initial reporter: rcc received a complaint via email.Please provide the date of event: october 11th, 2024.Please describe the issue in more detail? the syringe needle is found to not be fully twisted into the secured position in the syringe cap.The needle requires twisting with the cap to securely attach it to the barrel.Even with twisting, the needles may detach.The cap sometimes does not easily lock, even after tapping it closed.Please provide the batch#: or lot#: number? 4152464 and 4184699.Please provide the material#: or ref#: number? 309575 syringe, sterile, 3 ml, 21g x 1 in needle please share the captured photo of the event if available: not available any sample available for investigation? samples are available for both lot numbers.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event: the issue was not patient related.There was no harm to patient.The issue was discovered prior to patient involvement.
Additional Manufacturer Narrative
Pr (b)(4) - supplemental mdr - syringe needle connectivity issue.One sample from batch 4152464 and two samples from batch 4184699 were provided to our quality team for investigation.The reported defect was not observed in the samples received.The samples were also leak tested for leakage at luer and found to be acceptable.The condition observed is acceptable per product specification.Furthermore, a device history record review was completed for provided batch numbers 4152464 and 4184699.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• 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: 21416073
• Report Number: 1213809-2025-00115
• Device Sequence Number: 7899043
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750(11)240531(17)290531(10)4152464
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 4184699
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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