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 2020-03-06 for NASOPHARYNGEAL AIRWAY IPN042355 125410-000240 manufactured by Teleflex Medical Sdn. Bhd..
[183714429]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183714430]
Customer reported the device could not be placed well in the patient and may have been kinked. It was reported there was "no adequate oxygen supply possible (40%), stronger bleeding occurred" and the patient was in a "critical condition". The patient received manual bag ventilation and was stabilized. A new device was placed without issue. It was reported the patient's condition was "ok" before the procedure and the tube was difficult to insert. The patient's condition was reported as "fine" at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2020-00067 |
| MDR Report Key | 9802035 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-04-02 |
| Date Added to Maude | 2020-03-06 |
| 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 SDN. BHD. |
| Manufacturer Street | LOT NO : PT2577 JALEN PERUSAHAAN 4 KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASOPHARYNGEAL AIRWAY |
| Generic Name | AIRWAY, NASOPHARYNGEAL |
| Product Code | BTQ |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-03-04 |
| Model Number | IPN042355 |
| Catalog Number | 125410-000240 |
| Lot Number | 19GT54 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL SDN. BHD. |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |