MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-20 for FLEXITRUNK INFANT NASAL TUBING BC191 manufactured by Fisher & Paykel Healthcare Limited.
[176463597]
(b)(4). Method: the complaint bc191 flexitrunk infant nasal tubing was not returned to the fisher & paykel healthcare (f&p) for evaluation. Our investigation is therefore based on the information and photographs provided by the customer. Results: the visual inspection of the provided photograph revealed that the breathable film of the nasal tubing was torn. All flexitrunk nasal tubings are visually inspected and pressure tested before leaving the production line and those that fail are rejected. This suggests that the damage on the subject nasal tubing occurred after it was released for distribution. Our user instructions the accompany the flexitrunk infant nasal tubing state: "use caution when positioning the infant interface. Avoid excessive pull forces, sharp objects and tubing holders. Damage to the tubing may cause loss of pressure and require immediate replacement. " a caution insert is included in the packaging to remind the user to take extra care when handling the flexitrunk.
Patient Sequence No: 1, Text Type: N, H10
[176463598]
A distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that bc191 flexitrunk infant nasal tubing was found to be torn. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2019-00907 |
| MDR Report Key | 9096197 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-09-20 |
| Date of Report | 2019-08-21 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2019-02-28 |
| Date Added to Maude | 2019-09-20 |
| 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 DRIVE SUITE 100 |
| Manufacturer City | IRVINE 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, 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 | 2019-09-20 |
| Model Number | BC191 |
| Catalog Number | BC191 |
| Lot Number | 2100712483 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-20 |