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

Catalog Number	309646
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 5ml ll sp125 had leakage.The following information was provided by the initial reporter: material#: 309646 batch#: unknown it was reported by the customer that the 5 ml syringes that were being used were defective.They were leaking through the plunger, which would have resulted in failing the sterility test if they were sent out of the iv room for testing and use.Additionally, in two syringes we noticed metallic contaminants inside the syringes.There was one contaminant in each syringe, small and rose-gold in color.The contaminants look similar to metal shavings or glitter.I also noticed in a few of the defective syringes that the plunger appeared to be breaking off into small pieces inside the syringe.40 syringes were thrown away during compounding due to leaking and the 2 contaminated syringes.Verbatim: the customer noticed that the 5 ml syringes that were being used were defective.They were leaking through the plunger, which would have resulted in failing the sterility test if they were sent out of the iv room for testing and use.Additionally, in two syringes we noticed metallic contaminants inside the syringes.There was one contaminant in each syringe, small and rose-gold in color.The contaminants look similar to metal shavings or glitter.I also noticed in a few of the defective syringes that the plunger appeared to be breaking off into small pieces inside the syringe.40 syringes were thrown away during compounding due to leaking and the 2 contaminated syringes, resulting in loss of final product, (recipe makes 250 ephedrine syringes, however due to the transfer loss from transferring drug from the defective syringe to a new syringe, only 242 syringes were made), and large supply waste.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - leakage.As no physical or picture sample, or valid lot number was provided for evaluation, by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• 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: 23278439
• Report Number: 1213809-2025-00643
• Device Sequence Number: 5519331
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: (01)30382903096467(10)5127798
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 309646
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown