MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-5.0-3.5-12
Report
- Report Number
- 3011270181-2021-00056
- Event Type
- Injury
- Date Received
- November 22, 2021
- Date of Event
- November 3, 2021
- Report Date
- December 22, 2021
- Manufacturer
- AVANOS MEDICAL INC.
- Product Code
- BTR
- UDI-DI
- 00609038351124
- PMA / PMN Number
- K080821
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE DEVICE HISTORY RECORD FOR LOT CM0195002 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. AN UNUSED DEVICE FROM THE SAME LOT WAS PROVIDED BY THE CUSTOMER. EXAMINATION OF THE DEVICE REVEALED THAT IT WAS WITHIN SPECIFICATIONS AND FUNCTIONED NORMALLY. THE ORIGINAL DEVICE FROM THE REPORTED EVENT WAS NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. NO ROOT CAUSE COULD BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 22 DEC 2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC.. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-GHC-21-03495. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP- (B)(4).
IT WAS REPORTED THAT AN INTUBATED INFANT WAS DESATURATING AND NOT ACHIEVING SET TIDAL VOLUMES. IT WAS DISCOVERED THAT THE BLUE CONNECTOR ON THE END OF THE ENDOTRACHEAL TUBE (ETT) KEPT FALLING OFF AND WAS DIFFICULT TO KEEP ATTACHED TO THE TUBE. THE TUBE WAS ALSO KINKED. THE STAFF REPORTED "DIFFICULTY WITH MANAGEMENT OF AIRWAY AND BREATHING WITH MULTIPLE DISCONNECTIONS WHEN TRYING TO CHANGE FROM VENTILATOR TO AMBUBAG AND BACK AGAIN." THE PATIENT WAS EXTUBATED THE NEXT DAY AND IS AN INPATIENT AT (B)(6) HOSPITAL. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1749886 | MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-5.0-3.5-12 | VAP MICROCUFF ENDOTRACHEAL TUBES | BTR | AVANOS MEDICAL INC. | 35112 | CMO195002 | 00609038351124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |