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

Catalog Number	309643
Medical Device Problem Codes	Product Quality Problem (1506); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd syringe 10ml ll w/ndl 21x1-1/2 rb needle went through shield.Rcc received a complaint via email.Email(s) attached.Date: 23.02.2026 complaint number: (b)(4).Item number: 308-309643.Lot # / serial #: (b)(6).Sample available: yes.Item description: 10ml ll ster syringe w/ 21gx1.5" ndl reg.Incident description: as per client, the needle has gone through the protective cap and the plastic on the package - could have resulted in someone getting a needle stick injury.

• Brand Name: LUER-LOK PRECISIONGLIDE
• 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: 24618181
• Report Number: 1213809-2026-00125
• Device Sequence Number: 15987020
• Product Code: FMF
• UDI-Device Identifier: 00382903096435
• UDI-Public: (01)00382903096435(10)5280906
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 309643
• Device Lot Number: 5280906
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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