inforMED
MalfunctionKYW

BD SYRINGE ORAL 5ML CLEAR

Received Jun 1, 2026 · Event occurred May 11, 2026

Report 1213809-2026-00285 · MDR key 25356407

Device

Generic name

Container, Liquid Medication, Graduated

Catalog number

305218

Lot number

5094919

Product problems

  • Contamination /Decontamination Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT BD SYRINGE ORAL 5ML CLEAR CONTAINED FOREIGN MATTER. VERBATIM: VERBATIM: COMPLAINT VIA PHONE. CASE DESCRIPTION: A CUSTOMER REPORTED THE PRESENCE OF AN OILY SUBSTANCE IN THE PLUNGER AREA, SPECIFICALLY AT THE TIP OF THE SYRINGE. THIS ISSUE HAS BEEN OBSERVED IN APPROXIMATELY 300 UNITS, AFFECTING BOTH THE 5ML AND 10ML ORAL SYRINGES. THE CUSTOMER EXPRESSED UNCERTAINTY ABOUT WHETHER THIS CONDITION IS NORMAL OR EXPECTED. PRODUCT: 10 ML BD CLEAR ORAL SYRINGE / 5 ML BD CLEAR ORAL SYRINGE REF#: 205219 10ML / 305218 5ML LOT#: 6022380 / 5094919.