MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-09-23 for FLEXITRUNK INFANT NASAL TUBING BC191 manufactured by Fisher & Paykel Healthcare Ltd.
[176457868]
(b)(4). Method: the complaint bc191 flexitrunk nasal tubing was not received at fisher & paykel healthcare (f&p) for evaluation. (b)(6), consumer safety officer with the fda, confirmed that further information related to this complaint and the initial reporter are unavailable due to privacy reasons. Thus our investigation is based on the original information provided and our knowledge of the product. Results: the customer has stated that the bc191 tubing membrane was torn. Conclusion: we are unable to determine the root cause without further information. Previous investigations into this type of failure, however, have indicated 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. " "this product is intended to be used for a maximum of 7 days. " "do not use if product or packaging is damaged. " "always use pressure monitoring to verify that the patient is receiving the prescribed cpap level. " "do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to loss of cpap pressure. "
Patient Sequence No: 1, Text Type: N, H10
[176457869]
A medwatch report was received from fda which reported on behalf of a nurse that a bc191 flexitrunk infant nasal tube had a torn tubing membrane. It was reported that patient experienced desaturation & bradycardia with a return to baseline following interventions. No further patient consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2019-00905 |
| MDR Report Key | 9102344 |
| Report Source | OTHER |
| Date Received | 2019-09-23 |
| Date of Report | 2019-08-24 |
| Date Mfgr Received | 2019-08-24 |
| Date Added to Maude | 2019-09-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE CA 926182216 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182216 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
| 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 | 2019-09-23 |
| Model Number | BC191 |
| Catalog Number | BC191 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-23 |