MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-12-19 for PORTEX? INTUBATION STYLET 100/120/100 manufactured by Smiths Medical Asd, Inc..
[95315906]
Patient Sequence No: 1, Text Type: N, H10
[95315907]
Information was received indicating that the coating to the smiths medical portex? Intubation stylet stayed within the tube upon withdrawal during intubation. There was reported unknown adverse health outcome.
Patient Sequence No: 1, Text Type: D, B5
[113943454]
Patient Sequence No: 1, Text Type: N, H10
[113943455]
Photograph of the returned device indicates the device may not be a smiths medical device. Additional information received from the customer stated the device may be a teleflex product, but they are not sure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-02700 |
| MDR Report Key | 7131390 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-19 |
| Date of Report | 2018-01-26 |
| Date of Event | 2017-11-11 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2017-12-19 |
| 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 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING SA DE CV |
| Manufacturer Street | CARRETERA MIGUEL ALEM PARQUE INDUSTRIAL MONTERREY |
| Manufacturer City | APODACA NL, NL CP 66603 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 66603 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? INTUBATION STYLET |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2017-12-19 |
| Catalog Number | 100/120/100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-19 |