MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-20 for FLEXITRUNK INFANT NASAL TUBING BC190 manufactured by Fisher & Paykel Healthcare Limited.
[133937848]
(b)(4). The complaint bc190 flexitrunk infant nasal tubings is currently en route to fisher & paykel healthcare in (b)(4) for evaluation. We will provide a follow up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[133937849]
A healthcare facility in (b)(6) reported that the distal end of bc190 flexitrunk infant nasal tubings was torn. Discussions with the involved nurse and doctor revealed that this may have happened during inserting the tubing through the porthole of the incubator. There was no patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2019-00060 |
| MDR Report Key | 8263181 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-20 |
| Date of Report | 2018-12-20 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2018-08-28 |
| Date Added to Maude | 2019-01-20 |
| 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 | MS. FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DR., SUITE 100 IRVINE |
| Manufacturer City | CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, AUCKLAND 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXITRUNK INFANT NASAL TUBING |
| Generic Name | BZO |
| Product Code | BZO |
| Date Received | 2019-01-20 |
| Returned To Mfg | 2019-02-04 |
| Model Number | BC190 |
| Catalog Number | BC190 |
| Lot Number | 2100570085 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, AUCKLAND 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-20 |