PMI
Received Nov 22, 2023 · Event occurred Oct 12, 2023
Report 3009495876-2023-00001 · MDR key 18196256
Device
Generic name
Pmi Combo Pack - Cholangiogram Cather With Disposable Percutaneous Introducer
Manufacturer
Beilun Plastech IncModel number
PMIORCAP20Catalog number
PMIORCAP20
Lot number
030220401
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON OCTOBER 12TH A LAPAROSCOPIC CHOLANGIOGRAM CATHETER WITH PART NUMBER PMIORCAP20 AND LOT NUMBER 030220401 WAS TAGGED AS DEFECTIVE AFTER THE TIP DISCONNECTED FROM THE CATHETER AS THE SURGEON WAS INSERTING IT IN THE PATIENTS GALLBLADDER FOR DYE INFUSION FOR A CHOLANGIOGRAM. IT WAS NOT REPORTED THAT THE TIP WAS EVER LOOSE INSIDE THE PATIENT. NO HARM TO PATIENT OR COMPLICATIONS WERE REPORTED. NO ADVERSE EVENT WAS REPORTED. THE DEVICE IN QUESTION WAS NOT RETURNED FOR INVESTIGATION. THIS IS THE FIRST PRODUCT PROBLEM WITH PMIORCAP20 LOT NUMBER 030220401. ONLY ONE DEVICE FROM THE LOT OF 200 IS AFFECTED. THERE HAVE BEEN NO SIMILAR REPORTS FOR THIS LOT OR THIS DEVICE AS A WHOLE. PATIENT INFORMATION NOT AVAILABLE.