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

Catalog Number	309647
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material #309647.Lot #4303111.It was reported that the bd syringe 5ml ls sp125 tip broke.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Mckesson- i have a customer complaint about a box of 5cc syringes.The tip broke off of one.So, the meds had to be disposed of.I have the lot and expiration if needed.Product#: 309647.Lot#: 4303111.Additional information provided: 1.Any physical sample available for investigation of affected product? we do not have any physical samples available.I have pictures attached identifying the issue.2.Are you able to provide the dates of the events in the format of mm-dd-yyyy? if unknown, can state unknown.Unknown.3.How was the patient outcome? are there any clinical signs, health consequences or impact? no, just loss of drug.4.Any adverse event or serious injury reported to patient or health care professional? no.
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
Pr (b)(4) - supplemental mdr - tip breakage.One photo was provided to our quality team for investigation.The photo shows one loose syringe with an unknown blue attachment connected to the tip which is broken off at the base of the barrel.It cannot be confirmed from the photo provided that the reported condition originated at the manufacturing plant.Unused physical samples are required for a more thorough evaluation and potential root cause determination.Furthermore, a device history record review was completed for provided lot number 4303111.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 5ML LS 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: 21636054
• Report Number: 1213809-2025-00207
• Device Sequence Number: 15803104
• Product Code: FMF
• UDI-Device Identifier: 30382903096474
• UDI-Public: (01)30382903096474(11)241029(17)291031(10)4303111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/22/2025

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: 309647
• Device Lot Number: 4303111
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown