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 /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 lot # unknown (potential lot 5211788,4354977) verbatim: rcc received a complaint via email.Email(s) attached during compounding of lot #20251009-041c88 one syringe was found to have a foreign particulate that appeared dark in color and different than typical media particulate seen.The unit is available for return.10/9/2025 pcc-25-136 sterile syringe tray 10ml 309605 expiry 6/30/2030 and 11/30/2029 5211788, 4354977 foreign particulate dark strand 1.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.Two loose 10 ml luer-lok syringe (part number 309605) and two photos were received and evaluated.The sample showed significant damage to the plunger rod, while the photos depicted syringes filled with an unknown clear fluid containing dark, thread-like particulates of undetermined size.The foreign matter was not present in the received samples.These conditions are non-conforming to product specifications.The potential root cause for both the foreign matter in the fluid path and the plunger rod damage is associated with the assembly process.Furthermore, a device history record review for lot numbers 4354977 and 5211788 revealed no rejected inspections or quality issues during production that could have contributed to the 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.
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: 23444239
• Report Number: 1213809-2025-00691
• Device Sequence Number: 9066555
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054(17)300630(10)5211788
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: 309605
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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