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

Catalog Number	305060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl 18x1-1/2 blunt fill needle broke.Rcc received a complaint via email.Email(s) attached.An md was pulling up a medication from a vial using a blunt tip needle and the needle snapped in half creating a wps risk.Blunt tip needles are used to pull up medications, but are not used to inject into patients.This needle type is regularly used in dsa dermatology to pull up medications into a syringe.I have not been aware of any similar issues in the past with the blunt tip needles.The md was properly using the syringe/blunt tip needle to pull up a medication from a vial.The md stated they did not use any force or encounter any issue that put outside of normal strain on the device for its use.The needle snapped close to the hub, but the break was in the metal needle itself.Escalate to local product council representative - done.Notify pls materials manager of the product issue - done.Rrf to be filled out due to safety risk with a metal (blunt) needle snapping with normal use ¿ completing today.Wps risk information was shared with dsa dermatology staff/managers - done.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A total of sixty-seven samples were received for evaluation, of which sixty-six samples were provided in sealed blister packaging and one sample was received in an opened blister package.Visual inspection indicated that the sample received in the opened packaging was missing both the plastic shield and most of the needle, only a remaining portion of the needle measuring approximately 3 32 inches from the top of the needle hub was present, and the missing portion of the needle was not received.No additional information could be obtained from this sample.The remaining sixty-six samples showed no defects or imperfections.One photo was provided showing one of the received samples.Based on the investigation and sample evaluation, the reported condition was confirmed.Due to the absence of a complete sample for analysis, a probable root cause could not be determined.Furthermore, a device history record review was completed for the provided lot number 5182760.The review identified no rejected inspections or quality issues during production that could have contributed to the reported defect.

• 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: 24618183
• Report Number: 1213809-2026-00126
• Device Sequence Number: 10138089
• Product Code: FMF
• UDI-Device Identifier: 00382903050604
• UDI-Public: (01)00382903050604(17)300630(10)5182760
• 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): 04/01/2026

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: Health Professional
• Device Catalogue Number: 305060
• Device Lot Number: 5182760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/01/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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