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	11/10/2025
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 # 5241730.Verbatim: rcc received a complaint via email.Email(s) attached.During vi pharmancy coordinator rg identify a particle that has a hair like appearance in one of the 10ml syringes.Phenylephrine hci 1000 mcg in 10 ml of ns syringe finished.Lot 20251106-79b6c8.10ml syringe tray lot 5241730.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.One sample and six photos of a 10 ml luer-lok syringe (part number 309605) were received for evaluation.The sample, which had an unknown red cap attached, showed no defects, and the reported hair-like appearance was not observed.The photos displayed the same syringe from different angles, filled with an unknown clear fluid and capped with the same red cap.Minor blemishes were noted on the barrel but were within specification and not considered defects.Based on the sample and photos, the reported issue could not be confirmed.Additionally, a device history record review was completed for the provided lot number 5241730.The review showed no rejected inspections or quality issues during production that could have contributed to the reported defect.Complaints for this device and reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, and our business team regularly reviews the collected data to identify emerging trends.
Event or Problem Description
No additional information was provided.

• 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: 23723473
• Report Number: 1213809-2025-00754
• Device Sequence Number: 21481634
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054(17)300731(10)5241730
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/15/2026

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: 309605
• Device Lot Number: 5241730
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown