MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-23 for PORTEX RSP TRACHEAL TUBE HOLDERS H4052 manufactured by Smiths Medical International Ltd.
[2929012]
User facility reported that the tube holder is causing the tube to split. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[10015286]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2012-00402 |
| MDR Report Key | 2725552 |
| Report Source | 06 |
| Date Received | 2012-08-23 |
| Date of Report | 2012-08-20 |
| Report Date | 2012-08-20 |
| Date Reported to FDA | 2012-08-20 |
| Date Mfgr Received | 2012-07-30 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-09-11 |
| 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 | 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 RSP TRACHEAL TUBE HOLDERS |
| Generic Name | JAY - BREATHING TUBE SUPPORT |
| Product Code | JAY |
| Date Received | 2012-08-23 |
| Model Number | NA |
| Catalog Number | H4052 |
| Lot Number | 2116100 |
| ID Number | NA |
| Device Expiration Date | 2014-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| 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 | 2012-08-23 |