MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309657
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
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 bd syringe 3ml ll 200 s/c contained foreign matter.Verbatim: we found some black marks on plastipack 3 ml syringes for lot # 5255908.These marks appear to be on the syringe body itself.We require these to be sterile and uncontaminated, as these are used for drug transfer.Therefore, this is considered to potentially be a significant nonconformance on our end.As we do not own the design for these syringes, we are unable to please let me know what : what this material is.We can return all defects to bd for investigation.Whether or not this affects form-fit-function of the syringe, specifically surrounding sterilization and fluid pathway impact.If bd can share the risk profile identified from the investigation of this defect, so that we may retain traceability of this to our own impacted product.Additional information: can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2026.Kindly provide the number of products affected by this issue.At this time, the entirety of batch 5255908 sent to us is implicated.The specific total quantity implicated from this batch is unknown, as we only identified this issue by chance during the middle of production.Sample available is mentioned as yes, are you able to provide the address of the facility for us to ship the return label?yes to support our investigation, we kindly request that you share three to five samples for evaluation.We will send over a small bag containing some of what we found.

• Brand Name: BD LUER-LOK
• 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: 25114004
• Report Number: 1213809-2026-00240
• Device Sequence Number: 21419223
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573(10)5255908
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/10/2026

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: Other
• Device Catalogue Number: 309657
• Device Lot Number: 5255908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown