MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LL SP125; PISTON SYRINGE

Catalog Number	309646
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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 5ml ll sp125 had foreign matter.The following information was provided by the initial reporter: material # 309646.Batch # 5204460.Verbatim: rcc received a complaint via email.Situation: issue: the reporting caregiver popped the tops off both the sterile water and ampicillin vials.Cleaned the tops with an alcohol swab and peeled open the 5ml syringe package (normal- she did not break the packaging or cause damage in any way) and then a 20g needle, connected them and took off the needle cap.Punctured the sterile water, drawing up 5ml and transferring the 5 ml of water to the ampicillin.While injecting the water in, she noted a black particle in the syringe.She then stopped and pulled out the needle.Upon further inspection, she noted the black particle was mobile and not just markings on the exterior of the syringe.She then packaged up all of the supplies and placed them in a biohazard bag for reporting and did not remove the particle.Background: event date: 10/15/2025.Item description: syringe 5ml l/l.Intermountain health #: 93055444.Mfg #: 309646.Lot #: 5204460.Sample available: yes (if sample is available and would like it sent for your evaluation, please reply all, and attach a return shipping label via email).Assessment: credit requested: not at this time.Quantity affected: (b)(4) ea.Po # (b)(4).Sold to account # (b)(4).Ship to account # (b)(4).Was there injury? error occurred but did not reach the individual.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.One syringe with an attached safetyglide needle was provided to our quality team for investigation.A black foreign material was initially observed within the luer lock, however, it was inadvertently lost before fourier transform infrared spectroscopy analysis or photographic documentation could be obtained.Based on the available information, the most likely root cause of the foreign material inside the fluid path is associated with the assembly process.Furthermore, a device history record review for lot number 5204460 showed no rejected inspections or quality issues during production that could have contributed to the reported condition.

• Brand Name: BD SYRINGE 5ML LL SP125
• 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: 23584802
• Report Number: 1213809-2025-00726
• Device Sequence Number: 21181820
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: (01)30382903096467(17)300630(10)5204460
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/16/2026

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: 309646
• Device Lot Number: 5204460
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown