N-C CONN TUBE 6MM X1.8M
Received Sep 7, 2023 · Event occurred Aug 28, 2023
Report 9612030-2023-03818 · MDR key 17698337
Device
Generic name
Tubing, Noninvasive
Manufacturer
Cardinal HealthModel number
8888301606Catalog number
8888301606
Lot number
2303409264
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION AVAILABLE TO US, WE WERE UNABLE TO CONFIRM THE EVENT. IN THE MEANTIME, ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.
Description of Event or Problem
CUSTOMER REPORTS: THE SURE-GRIP COMES OFF. ABOUT 80% OF THE PRODUCT DISENGAGES FROM THE SURE-GRIP, THUS, THE CUSTOMER USES THE PRODUCT BY CUTTING OFF THE SURE-GRIP PART. THE PERIOD OF USE IS 1 TO 3 DAYS. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2023, THE SURE GRIP HAS BEEN IDENTIFIED AS THE BLUE CONNECTOR WHICH DID DETACH. IT APPEARS THAT THE CONNECTOR WAS LOOSE, MOST LIKELY DUE TO INSUFFICIENT ADHESIVE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE NUMBER OF PATIENTS IS UNKNOWN.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.