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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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 barrel cracked.The following information was provided by the initial reporter: material: 309605, batch#: unknown (provided lot: 5121433, 5211788).Rcc received a complaint via email.During compounding of lot#: 20251008-96d150 the following syringe issues were noticed, 1 cracked syringe - available for return.1 syringe with no markings ¿ not available for return.1 syringe with faded markings¿ not available for return.1 syringe will almost no markings¿ not available for return.2 with foreign particulate on the rubber stopper (does not appear to move) ¿ not available for return.Two different lot# were used in compounding so i¿m unsure the lot# in which the complaints are from.Date of the complaint is on (b)(6) 2025.No patients are involved.On (b)(6) 2025: pcc-25-135, sterile syringe tray 10ml, 309605 expiry 4/30/2309 and 6-30-2030 5121433, 5211788, syringe markings, missing markings, faded markings, 3.On (b)(6) 2025: pcc-25-135, sterile syringe tray 10ml, 309605, expiry 4/30/2309 and 6-30-2030 5121433, 5211788, foreign particulate, sitting on the stopper 2.On (b)(6) 2025: pcc-25-135, sterile syringe tray 10ml, 309605, expiry 4/30/2309 and 6-30-2030 5121433, 5211788, cracked syringe, barrel cracked, 1.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - barrel cracked.A photo and video of a 10 ml luer-lok syringe (part number 309605) were reviewed.The photo shows minor voids in the print on two graduation lines; however, more than 50% of the markings are intact, meeting specifications.The video depicts a loose syringe filled with an unknown clear fluid, capped with an unidentified white tip, and an air bubble visible near the stopper.No reported defects such as cracks, missing or faded markings, or foreign particles were observed in either the photo or video.The syringe condition appears acceptable per product specifications; however, a physical sample is required for a thorough evaluation and root cause analysis.Additionally, a device history record review was completed for the provided lot numbers 5121433 and 5211788.The review showed no rejected inspections or quality issues during 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 in trend reports and monitored monthly, and our business team regularly reviews the collected data to identify emerging trends.

• 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: 23432705
• Report Number: 1213809-2025-00687
• Device Sequence Number: 14610592
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054(17)300430
• 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): 12/05/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown