MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-10-16 for HUDSON STYLET,SOFT TIP,6 FR 5-15120 manufactured by Teleflex Medical.
[126118051]
Qn# (b)(4). The device involved has not been received by the manufacturer for evaluation at the time of this report. A device history record investigation did not show issues related to this complaint. A record assessment (fmea) was conducted and no update is required. Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determine the root cause. Root cause is unknown. Corrective actions cannot be established. If the device sample becomes available at a later date, this report will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[126118052]
Customer complaint alleges "during the intubation of the child, the rigid guide was used with a portex endotracheal tube (manufactured by smith medical) d 2. 5 ref 100/105/025. A part of the guide remained in the tube during removal. (cont. ) the patient was extubated and the detached part of the guide was removed from the young patient. " it was reported there was no consequence for the child. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2018-00820 |
| MDR Report Key | 7970816 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-16 |
| Date of Report | 2018-10-01 |
| Date of Event | 2018-09-29 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2018-10-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON STYLET,SOFT TIP,6 FR |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2018-10-16 |
| Returned To Mfg | 2018-10-31 |
| Catalog Number | 5-15120 |
| Lot Number | 73C1800199 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-16 |