MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-11-16 for PORTEX? INTUBATION STYLET 100/120/200 manufactured by Smiths Medical Asd; Inc..
[127559827]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[127559828]
Information was received indicating that while attempting to pass a smiths medical portex? Intubation stylet through the lumen of an endotracheal tube, it causes adhesion and is making it difficult to intubate the patient since it does not pass perfectly. It was also noted that the guidewire is unable to be removed. There were no reported adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-08443 |
| MDR Report Key | 8081916 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-08-10 |
| Device Manufacturer Date | 2016-06-20 |
| Date Added to Maude | 2018-11-16 |
| 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 | 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 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? INTUBATION STYLET |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2018-11-16 |
| Catalog Number | 100/120/200 |
| Lot Number | 3223991 |
| 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 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-16 |