MalfunctionJCY
4F X 55CM SINGLE PRO-PICC CT
Received Oct 16, 2014 · Event occurred Aug 25, 2014
Report 2518902-2014-00067 · MDR key 4188447
Device
Generic name
Infusion Catheter
Manufacturer
MedcompModel number
MRCTP41017Catalog number
MRCTP41017
Lot number
MBTR000
Product problems
- Detachment Of Device Component
- Peeled/Delaminated
Patient
52 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING ROUTINE PLACEMENT OF A PICC LINE, THE DILATOR SHEATH BECAME DETACHED FROM THE WINGED SET PRIOR TO BREAKING AND PEELING APART.
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED. THE DEVICE SAMPLE WAS FORWARDED TO THE MANUFACTURING FACILITY FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.