MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK; PISTON SYRINGE

Catalog Number	309605
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
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 10ml ll tip bulk convenience pak had foreign matter.The following information was provided by the initial reporter: material#: 309605, batch#: 5211789.Rcc received a complaint via email.Upon visual inspection of syringes, it was discovered that there were 205 cosmetic defects relating to off-colored matter embedded in the grooves of the syringe.Solution does not touch that area, and it does not move.The matter also appears to be colored plastic like particles.Item: d309605, lot#: 5211789, expiry: 06/30/2030.
Additional Manufacturer Narrative
(b)(4).Follow up.A cosmetic concern was reported involving off colored material embedded in the syringe grooves.To support the investigation, the quality team received one photograph of a 10ml luer lok syringe for evaluation.The image is a close up of the syringe barrel tip area and includes a blue circle highlighting an unknown, clear colored irregularity within the barrel collar.The size of the irregularity cannot be determined from the photograph, and the image alone is insufficient to confirm whether the condition originated at the canaan plant.A physical sample is required to enable a comprehensive evaluation and support potential root cause determination.A device history record review was completed for material number 309605, lot 5211789.The review confirmed that all required visual inspections were performed and that no quality notifications were documented related to the reported condition.The lot was inspected and accepted in accordance with the approved inspection control plan, released for shipment, and is considered compliant with applicable product specification requirements.To date, no additional similar events have been reported for this lot.Based on the investigation, including evaluation of the photographic sample, the customer reported condition could not be confirmed.

• Brand Name: BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
• 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: 23812386
• Report Number: 1213809-2025-00780
• Device Sequence Number: 13114022
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054(17)300630(10)5211789
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/22/2026

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: Other
• Device Catalogue Number: 309605
• Device Lot Number: 5211789
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown