MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2020-03-17 for PORTEX BIVONA FLEXTEND? TTS? TRACHEOSTOMY TUBE XT18ES50NSC980N manufactured by Smiths Medical Asd; Inc..
[183874646]
Information was received indicating that the cuff to a smiths medical portex bivona flextend? Tts? Tracheostomy tube was found leaking upon assessing the patient's drop-in oxygen saturation level. The cuff was re-inflated with 3mls of water and was later checked to find only 0. 5mls of water left. Mother stated that the ent and respiratory therapy were notified with instruction to re-inflate the cuff with water when needed until the replacement trach tube arrived. The trach tube was eventually changed out. It was reported that part of the wedge used to remove the tube had caused a mucous plug which was relieved by suctioning. The patient's mother reported an elevated heart rate at that time but then resolved. There were no further reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02109 |
| MDR Report Key | 9845351 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| 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 | 5700 WEST 23RD AVENUE |
| Manufacturer City | GARY, IN |
| 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 | XT18ES50NSC980N |
| Catalog Number | XT18ES50NSC980N |
| 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 |