MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-26 for PORTEX RSP TRACHEAL TUBE HOLDERS H4051 manufactured by Smiths Medical International Ltd..
[15513114]
User facility reported that the lock mechanism on the endotracheal tube was too tight to allow passage of a suction catheter. As a result it was necessary to release the locking mechanism to allow passage of the suction catheter. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[15753005]
Customer has not yet returned the device to the mfr for device eval. When and if the device becomes available and is returned and evaluated the mfr will file a f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2012-00621 |
| MDR Report Key | 2945193 |
| Report Source | 06 |
| Date Received | 2012-12-26 |
| Date of Report | 2012-12-20 |
| Report Date | 2012-12-20 |
| Date Reported to FDA | 2012-12-20 |
| Date Mfgr Received | 2012-11-21 |
| Date Added to Maude | 2013-02-21 |
| 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 | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDRY RD. |
| Manufacturer City | HYTHE, KENT |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX RSP TRACHEAL TUBE HOLDERS |
| Generic Name | JAY - BREATHING TUBE SUPPORT |
| Product Code | JAY |
| Date Received | 2012-12-26 |
| Model Number | NA |
| Catalog Number | H4051 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Address | HYTHE, KENT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-26 |