N-C CONN TUBE 5MM X3.0M
Received Jul 14, 2023 · Event occurred Jul 5, 2023
Report 9612030-2023-03762 · MDR key 17327159
Device
Generic name
Tubing, Noninvasive
Manufacturer
Cardinal HealthModel number
8888301523Catalog number
8888301523
Lot number
2219612664
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
PLEASE DISREGARD THIS REPORT NUMBER (9612030-2023-03762). FURTHER INFORMATION DETERMINED THAT AN DETACHMENT OF THIS DEVICE IS NOT FDA REPORTABLE.
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: THERE WERE THREE CASES WHERE THE BLUE GRIP CAME OFF DURING USE. ALL THREE OF THE ACTUAL PRODUCTS ARE DISCARDED DUE TO BLOOD ADHESION AND CANNOT BE COLLECTED.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. H3: DEVICE EVALUATION COMMENT - THE CUSTOMER STATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED DUE TO CONTAMINATION.