MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-12-19 for HUDSON SHERI-I-SLIP INTUBATING STYLET 5-15102 manufactured by Teleflex Medical.
[95466911]
(b)(4). The device involved in this complaint has not been received by the manufacturer at the time of this report. The investigation into this complaint is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[95466912]
Customer complaint alleges "after the intubation of a bad child on the birth row, the stiletto is going to be pulled out of the tube. It is stuck and some need to be used forces to pull it out. As it is out, it is noted that there missing some of the plastic part from the tip of the stylet. The tube is taken therefore, re-open without ventilation. Subsequent can push the left plastic material out of the stylet tube. " there was no report of any material left in the patient. There was no report of injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-01299 |
| MDR Report Key | 7130309 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-19 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-12-21 |
| Date Added to Maude | 2017-12-19 |
| 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 | 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 SHERI-I-SLIP INTUBATING STYLET |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2017-12-19 |
| Catalog Number | 5-15102 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-19 |