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..
[15154435]
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
[15274832]
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 | 2183502-2012-00401 |
MDR Report Key | 2725005 |
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 | BOUNDRY 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 UK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2012-08-23 |