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

Catalog Number	309657
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll 200 s/c label content was incorrect.Complaint via email.Email(s) attached.This is the official request for investigation for non-conformance: nc-(b)(4).Nc number nc-(b)(4).Capa/act number act-064862.Mm# 10500500 3 ml syringe supplier material (catalog) part number 309657 supplier bd plastics is the material bought directly from supplier? no this is purchased through (b)(6).Po number (b)(4).Supplier lot number 5133990 coc or coa of the impacted material n/a summary of the defect based on the nc conclusion (failure mode / when, who, where, how, what) description of issue: apn-044452: initiate the supplier investigation for a mislabeled container of 3ml syringes shipped from to prince sterilization.One carton from the master pack was labeled as 5 ml, however, the inner container contained 3 ml syringes and contained only 125 quantities instead of 200.Is the affected material available no: they were dispositioned as scrap.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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: 24761541
• Report Number: 1213809-2026-00163
• Device Sequence Number: 9266912
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573(17)300430(10)5133990
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/27/2026

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: 309657
• Device Lot Number: 5133990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown