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 2018-12-12 for FLEXITRUNK INFANT NASAL TUBING BC191 manufactured by Fisher & Paykel Healthcare Limited.
[130469026]
(b)(4). Method: the complaint bc191 flexitrunk infant nasal tubing was not returned to the fisher & paykel healthcare (f&p) regional office. Our investigation is therefore based on the information and photographs provided. Results: the photographs provided showed that the breathable film of the nasal tubing was torn. A lot check was performed and to date there were no other devices for this lot number to have been identified to be torn. Conclusion: the tear is likely to have been caused by pulling of the nasal tubing. 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
[130469027]
A distributor in (b)(6) reported on behalf of a hospital that bc191 flexitrunk infant nasal tubing was torn when taking out of the box. This was observed before use on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2018-01065 |
| MDR Report Key | 8158612 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-12-12 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-11-13 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-12-12 |
| 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, 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 | 2018-12-12 |
| Model Number | BC191 |
| Catalog Number | BC191 |
| Lot Number | 2100522894 |
| 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, AUCKLAND 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |