MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-17 for PORTEX BIVONA FLEXTEND? TTS? TRACHEOSTOMY TUBE 67PFSS50 manufactured by Smiths Medical Asd; Inc..
[183875080]
Three complaint files are related to each other. However, only two files are found reportable. Cc-0067641 was found not reportable as fault was found at pre-use check. 3012307300-2020-02099-0067642 is the third complaint in the series.
Patient Sequence No: 1, Text Type: N, H10
[183875081]
Information was received indicating that immediately following placement of a smiths medical portex bivona flextend? Tts? Tracheostomy tube the patient desaturated and turned blue. The patient was then bagged while the trach tube was removed, and the cuff massaged. The cuff was re-inflated but was reported to only inflate to 30-40%. A second cuff was attempted to be used but once again, cuff would not inflate fully. Subsequently, one of the patient's old tracheostomy tubes was used but was reported to have mold inside the cuff. The patient recovered but is currently awaiting further replacement trach tubes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02112 |
| MDR Report Key | 9845355 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-17 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD; INC. |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX BIVONA FLEXTEND? TTS? TRACHEOSTOMY TUBE |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-17 |
| Model Number | 67PFSS50 |
| Catalog Number | 67PFSS50 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS,, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-03-17 |