MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK LUER-LOK; PISTON SYRINGE

Catalog Number	309658
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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 bd syringe 3ml ll euro 200 s/c contained foreign matter.A clinical trial site has noted that there are black blemishes/spots visible on or in bd syringes.Please see attached picture evidence.Confirmed products and lot numbers so far that are confirmed are below: bd 1ml syringes, lot: 4354445, expiry: 2029-11-30, bd 3ml syringes, lot: 4352796, expiry: 2029-11-30, bd 3ml syringes, lot: 5072741, expiry: 2030-02-28.Out client noted the blemishes/ black spots on (b)(6) 2026.Fcs were informed on the 26th january.
Additional Manufacturer Narrative
(b)(4) follow up: two photos were received showing three loose, fully assembled 3 ml ll syringes part number 309658 with printing defects.In the first photo, one syringe is partially missing the bd logo and two ink dots on the barrel.The second photo shows three syringes with one or more unintended ink dots in the non-scale marking area.These conditions are non-conforming to product specifications, and the missing print and ink dot defects are likely associated with the marking process.A device history record review was completed for material number 309658, lots 4352796 and 5072741.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lots met acceptance criteria per the inspection control plan, were approved for shipment, and are in compliance with applicable product specifications.

• Brand Name: BD PLASTIPAK LUER-LOK
• 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: 24367803
• Report Number: 1213809-2026-00070
• Device Sequence Number: 9660608
• Product Code: FMF
• UDI-Device Identifier: 00382903096589
• UDI-Public: (01)00382903096589(11)241217(17)291130(10)4352796
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 309658
• Device Lot Number: 5072741
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown