inforMED
MalfunctionKYW

NOT APPLICABLE

Received May 8, 2026 · Event occurred Apr 21, 2026

Report 1213809-2026-00244 · MDR key 25125590

Device

Generic name

Container, Liquid Medication, Graduated

Catalog number

305210

Lot number

5094870

Product problems

  • Contamination

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT BD SYRINGE ORAL 3ML AMBER CONTAINED FOREIGN MATTER. 10MG (NUMBER OF UNITS INSPECTED: (B)(4); SYRINGE PRINTING DEFECT: 6; PLUNGER RUBBER STOPPER DEFECT: 3; SCRATCH: 1) 7.5MG (NUMBER OF UNITS INSPECTED: (B)(4) SYRINGE PRINTING DEFECT: 1) 5MG (NUMBER OF UNITS INSPECTED: (B)(4); SYRINGE PRINTING DEFECT: 3; PLUNGER RUBBER STOPPER DEFECT: 1; SCRATCH: 1; EXTERNAL SURFACE CONTAMINATION: 1; ADHERED FOREIGN MATTER: 1) 2.5MG (NUMBER OF UNITS INSPECTED: (B)(4); SYRINGE PRINTING DEFECT: 9; SCRATCH: 1; EXTERNAL SURFACE CONTAMINATION: 1). CUSTOMER RESPONSE RECEIVED ON 4/30/2026 7:44 PM - (B)(6). COULD YOU PLEASE PROVIDE THE CATALOGUE NUMBER OF THE DEFECTIVE PRODUCT? 60000310 COULD YOU PLEASE PROVIDE THE BATCH NUMBER OF THE DEFECTIVE PRODUCT? 5094870 COULD YOU PLEASE CONFIRM IF DEFECTS WERE NOTICED PRIOR TO USE? YES WAS THERE ANY PATIENT IMPACT OR HARM? NO ¿ WAS NOT ADMINISTERED TO ANY PATIENT AS CUSTOMER HAD INSPECTED PRODUCTS BEFORE USAGE AND FOUND THE DEFECT PRIOR.