ICU MEDICAL, INC. TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED; CATHETERS AND ACCESSORIES
|
Back to Search Results |
|
Catalog Number 412290401 |
Device Problem
Material Rupture (1546)
|
Patient Problem
Injury (2348)
|
Event Date 10/09/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is not expected to return for evaluation.The reported complaint cannot be confirmed without the returned sample.
|
|
Event Description
|
The event involved a td catheter, 7f, 4 lumen, 110 cm, heparin coated that was reported that the balloon burst open when used.There was a report of an unspecified injury.No additional details were provided.
|
|
Manufacturer Narrative
|
Testing and investigation confirmed there were no product samples or photographs returned for investigation.Therefore, the complaint could not be confirmed and a complete investigation was not performed without the sample or mating device.A manufacturing batch record review was completed and there were no non-conformances found that would have contributed to the reported event.
|
|
Search Alerts/Recalls
|
|
|