MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 25X1 RB; PISTON SYRINGE

Catalog Number	309581
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
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
Material # 309581.Batch # 3354844.It was reported that the bd syringe 3ml ll w/ndl 25x1 rb had foreign matter.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.This evening, we were unable to use a syringe for my wife¿s b-12 injection.The needle has what looks like excess glue/sealant at the tip, as well as further down the needle (photo will be attached).Unfortunately, this was only noticed when we tried to use it (and it would not penetrate the skin completely).We have saved this unit for you if you would like it to be sent back for further investigation.Please advise of a solution for this quality control issue, and follow up with us concerning replacement for the faulty piece.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter one sample and one photo were provided to our quality team for investigation.A visual inspection revealed epoxy drips on the needle.This defect could occur during the assembly process if a jam occurs at the cannulator, causing the epoxy to drip onto the needle.Furthermore, a device history record review was completed for provided lot number 3354844.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 3ML LL W/NDL 25X1 RB
• 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: 21802400
• Report Number: 1213809-2025-00251
• Device Sequence Number: 15305887
• Product Code: FMF
• UDI-Device Identifier: 30382903095811
• UDI-Public: (01)30382903095811(11)231220(17)281231(10)3354844
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: Lay User/Patient
• Device Catalogue Number: 309581
• Device Lot Number: 3354844
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown