MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 21X1 RB; PISTON SYRINGE

Catalog Number	309575
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
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
It was reported that the bd syringe 3ml ll w/ndl 21x1 rb stopper was jammed / insecure.The following information was provided by the initial reporter: material#: 309575, lot#: 4354917.Rcc received a complaint via email.Today, we found two bd plastipak 3ml syringe-luer-lok tip with bd precisionglide needle.(lot#: 4354917) that the rubber tip/stopper was not properly applied to the plunger.This caused the medication to leak around the plunger and the luer-lok needle.I wanted to bring this to your attention in case there have any other reported defective syringes.Additional information provided: 1.Could you please reconfirm an exact date of event in this format mm-dd-yyyy? 7/8/2025.2.Can you share any physical sample if available for investigation? 3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Medication leaked and unable to administer to patient.Medication had to be wasted and replaced.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A sample and photo of a 3ml luer-lok syringe with 21x1" needle (part number 309575), batch 4354917, were evaluated.The syringe, sealed in its packaging, showed a non-conforming condition where the stopper was not securely attached to the plunger rod.Potential root cause for the stopper insecure defect is associated with the assembly process.Furthermore, a device history record review was completed for provided lot number 4354917.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD SYRINGE 3ML LL W/NDL 21X1 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: 22548796
• Report Number: 1213809-2025-00485
• Device Sequence Number: 9283373
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750(17)291130(10)4354917
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 309575
• Device Lot Number: 4354917
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown