MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-03-16 for MICROCUFF ADULT ENDOTRACHEAL TUBE 35217 103521703 manufactured by Avanos Medical Inc..
[183794483]
A review of the device history record is in-progress. The actual complaint product was not returned for evaluation. Root cause could not be determined. All information reasonably known as of (b)(6) 2020 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. 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 inc. Complaint database and identified as complaint (b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[183794484]
Avanos medical inc. Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient. This is the first of two reports. Refer to 3011270181-2020-00047 for the second report. It was reported that the "pre-filled control balloon maintains the cuff tightness before intubation, and after intubation the patient's air escapes and the cuff leaks. At the last intubation, two tubes from this series were used and both experienced this problem. " "replacement of the intubation tube and intubation through the mouth is planned... Visible swelling in the mouth and throat [was noted]? The tube was removed due to a leak in the cuff (functional cuff before intubation). Another intubation with a new tube was performed - the cuff was leaking again. Another endotracheal tube could not be reinserted into the trachea. " airway patency was maintained with a laryngeal mask until naso-tracheal intubation was performed. 500ml gelaspanu, hydrocortisone 200mg and theospirex 200mg were additionally given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2020-00046 |
| MDR Report Key | 9837930 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | COMMAND MEDICAL NICARAGUA SA |
| Manufacturer Street | KM 12.5 CARRETERA NORTE PARQUE INDUSTRIAL LAS MERCEDES |
| Manufacturer City | MANAGUA, MANAGUA |
| Manufacturer Country | NU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROCUFF ADULT ENDOTRACHEAL TUBE |
| Generic Name | VAP MICROCUFF ENDOTRACHEAL TUBES |
| Product Code | BTR |
| Date Received | 2020-03-16 |
| Model Number | 35217 |
| Catalog Number | 103521703 |
| Lot Number | UM6175XXX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |