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

Catalog Number	309605
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
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 10ml ll tip bulk convenience pak contained foreign matter.Complaint via email.During visual inspection of lot: 20260312 651b82 phenylephrine hci 1000 mcg in 10 ml of ns syringe, 1 syringe was discovered to have a foreign particulate.Unit is available for return upon request.Details for your investigation: product: 50ml syringe, lot number: 5282734, part number: 309653, number of defective: units 1, defect type: during visual inspection 1 syringe was found to contain a foreign particulate, product complaint: (b)(4), quantity: (b)(4).Additional information received on 20mar2026.Can you please provide an exact date of event in format ddmmmyyyy? the product was created 3/12/2026.The particulate was discovered on (b)(6) 2026.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.N/a no patient usage at this point.The description states, ¿during visual inspection of lot: 20260312 651b82 phenylephrine hcl 1000 mcg in 10 ml of ns syringe.¿ however, the provided material number: 309653.Corresponds to a 50 ml product.Could you please recheck and confirm which material is impacted? the part number impacted is 309605.The lots associated with this lot are 5296589, 5303754, 5310147.Could you please reconfirm the affected quantity.Lot: 5303754 (b)(4).Lot: 5310147 (b)(4).Lot: 5296589 (b)(4).The foreign matter was inside the fluid pathway of the syringe.

• 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: 24818518
• Report Number: 1213809-2026-00182
• Device Sequence Number: 18565330
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054(10)5296589
• 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): 05/29/2026

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: 309605
• Device Lot Number: 5296589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 06/02/2026
• 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