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

Catalog Number	309581
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
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 3ml ll w/ndl 25x1 rb had leakage.Verbatim: complaint via email.Email(s) attached.Contact name: x contact number: x contact email (if available): item(s): 309581 lot(s): n/a date incident occurred (b)(6) 2026 was the patient impacted? if yes, describe: yes, the syringes were leaking and the patient was unable to use them.Is a sample available?: no customer request?: replacement syringes lot unknown (b)(6) 2026 vmf customer discarded medication wasted but was able to administer with another syringe.Customer purchases from pharmacy of america.

• Brand Name: BD PLASTIPAK 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: 25375292
• Report Number: 1213809-2026-00291
• Device Sequence Number: 18472679
• Product Code: FMF
• UDI-Device Identifier: 00382903095810
• UDI-Public: (01)00382903095810
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/05/2026

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: Lay User/Patient
• Device Catalogue Number: 309581
• Device Lot Number: UNKNOWN
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 06/10/2026
• 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