MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-08 for PORTEX RSP TRACHEAL TUBE HOLDERS H4052 manufactured by Smiths Medical Internatioal Ltd.
[3250157]
User facility reported that an infant self-extubated during product use. The report states that the nurse responded to an alarming ventilator and discovered the ett lying in the bed with the holder still attached to the baby's face. The infant was re-intubated and there was no permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[10670553]
Customer has not yet returned the device to the mfr for device evaluation. When and if the device becomes available and is returned and evaluated the mfr will file a follow-up detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2013-00139 |
| MDR Report Key | 3059540 |
| Report Source | 06 |
| Date Received | 2013-04-08 |
| Date of Report | 2013-04-05 |
| Date of Event | 2013-03-03 |
| Date Facility Aware | 2013-03-03 |
| Report Date | 2013-04-05 |
| Date Reported to FDA | 2013-04-05 |
| Date Mfgr Received | 2013-03-06 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-04-17 |
| 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 RD |
| 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 | 2013-04-08 |
| Model Number | NA |
| Catalog Number | H4052 |
| Lot Number | 2322827 |
| ID Number | NA |
| Device Expiration Date | 2016-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INTERNATIOAL LTD |
| Manufacturer Address | HYTHE, KENT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-08 |