MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/BLUNT PLASTIC CANN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303346
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
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/blunt plastic cann had foreign matter.The following information was provided by the initial reporter: material #:303346 batch#:5035774.Verbatim: i pulled up toradol yesterday on a patient and noticed a little sliver of what i assumed was a piece of the stopper.I originally thought it was a fluke, but today i noticed it again while pulling up zofran.Immediately let supervisor know and personally called charge nurses from cicu, 3n, transitions, and ob and informed them to pull all 3ml syringes until further notice.I encouraged them to be cautious using any of the other size of the bd blunt tip syringes.I have the syringe at the charge nurse desk in the ed.It is hard to see but and may need a better lighting, but the foreign body is in the syringe.I cannot verify with 100% accuracy, but i am 95% sure the serial # is (b)(6) and lot # is 5035774.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.One sample and two photos were provided to our quality team for investigation.Upon visual inspection, a sticky residue was noted extending from approximately the 1½ ml mark downward.The residue's texture and appearance were consistent with adhesive remnants, likely from a previously applied and removed sticker.Additionally, a grey, squishy, foreign material was observed on the stopper, located within the fluid path.This condition is considered non-conforming per the product specifications.The potential root cause of the foreign matter in fluid path defect is associated with the assembly process.Furthermore, a device history record review was completed for provided lot number 5035774.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.

• Brand Name: BD SYRINGE 3ML LL W/BLUNT PLASTIC CANN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 21908788
• Report Number: 1213809-2025-00307
• Device Sequence Number: 4221313
• Product Code: FMI
• UDI-Device Identifier: 00382903033461
• UDI-Public: (01)00382903033461(11)250204(17)300131(10)5035774
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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): 06/13/2025

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: Health Professional
• Device Catalogue Number: 303346
• Device Lot Number: 5035774
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown