Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/21/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
|
|
Event Description
|
It was reported the trach tube 'snapped' while in use with a patient.The customer stated the item number was 67pfp40 or 67pfps40.No patient injury was reported.No other information was provided.
|
|
Manufacturer Narrative
|
H6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available., corrected data: e4: correction: customer reported to fda: no information.
|
|
Search Alerts/Recalls
|