MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LL SP125; PISTON SYRINGE

Catalog Number	309646
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 5ml ll sp125 barrel cracked.The following information was provided by the initial reporter: material # 309646.Batch # unknown.Verbatim: rcc received a complaint via email.Email(s) attached.I'd like to submit a concern about a syringe malfunction.Bd syringe 5 ml luer lok tip syringe product # 309646.Lot 515404.Exp 04/30/30.There was a crack in the syringe.When it was used, medication sprayed out of the side of the syringe.Additional information provided: 1.Can you please provide an exact date of incident in this format mm-dd-yyyy? (b)(6) 2025.2.Is there a photo/video or physical sample available showing the reported issue? if yes, please provide the address of the facility for us to ship the return label? n/a.3.It appears that the provided lot number [515404] may contain a typo.Could you please verify and confirm the correct lot number? i've confirmed and this is the lot number that was provided in the incident report.1.Which part of the syringe was crack.Top of the barrel/bottom of the luer lock 2.Please confirm on any harm or patient impact.Drug squirted out sideways and into technician's eye - no lasting harm.3.Kindly provide the number of occurrences.Once.
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
Additional information: drug squirted out sideways and into technician's eye - no lasting harm the eye was rinsed with water in the eye wash station.No further medical intervention was required.
Additional Manufacturer Narrative
Additional information: (b) added event details.Investigation results: root cause couldn't be determined due to unavailability of sample information.A complaint history record (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.

• Brand Name: BD SYRINGE 5ML LL SP125
• 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: 23835258
• Report Number: 1213809-2025-00787
• Device Sequence Number: 9268571
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: (01)30382903096467
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 309646
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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
• Patient Sex: Unknown