MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-19 for PORTEX BIVONA TRACHEOSTOMY TUBE manufactured by Smiths Medical Asd; Inc..
[184264488]
The available information from the customer does not indicate as to which patient expired nor does it state which tracheostomy tubes are related to which patient. It was reported that the leak or tear were new issues that occurred as both patients had been at the hospice facility for several months with no issues. The following five complaints have been submitted and are all related. 3012307300-2020-02139-0067798. 3012307300-2020-02140-0067800. 3012307300-2020-02141-0067801. 3012307300-2020-02142-0067802. 3012307300-2020-02143-0067803.
Patient Sequence No: 1, Text Type: N, H10
[184264489]
Information was received on two separate patients, indicating that 24-48 hours following placement of a smiths medical portex bivona tracheostomy tube, was found to be compromised. It was reported that trach was changed out until the issue was resolved. Both patients were noted to be ventilator dependent, on hospice and receiving high pressures from the ventilator. Unfortunately, one patient later expired. It was reported that the patient death was not related to the trach tube. Patient one: received two trach tube change outs 24-48 hours following placement with a cuff tear of pin-hole cuff leak noted. Patient two: received three trach tube change outs 24-48 hours following placement with a cuff tear of pin-hole cuff leak noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02141 |
| MDR Report Key | 9857793 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-19 |
| 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 INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, KENT CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX BIVONA TRACHEOSTOMY TUBE |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-19 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-19 |