MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-19 for FLEXITRUNK INFANT NASAL PRONGS BC3020 manufactured by Fisher & Paykel Healthcare Limited.
[80511229]
The fisher & paykel healthcare flexitrunk interface is designed to deliver non-invasive positive pressure ventilation to a spontaneously breathing patient weighing up to 10 kilograms in a hospital or clinical setting where the patient is adequately monitored by trained medical staff. The bc3020 flexitrunk infant nasal prongs are designed to be used with the flexitrunk interface. Method: the complaint nasal prongs were not available for investigation as they were not returned by the hospital. Attempts were also made to obtain additional information regarding the reported incident but no response was received from the hospital. Our investigation was carried out based on the initial information provided by the hospital and the results of previous investigations of similar complaints. Results: the hospital stated "the width between the prongs seems too narrow on the smaller sizes of prongs and that is the culprit". This was a general report about this particular size of prongs causing breakdown at the infants' nares. Conclusion: fisher & paykel healthcare currently makes 11 different sizes of prongs. With regard to the reported septal injury, fisher & paykel healthcare recognises that correct cannula size selection, correct prong placement and fit, and careful patient monitoring are vital in ensuring the patient receives the benefits of nasal therapy while minimising the potential for skin irritation or septal injury. In terms of sizing, there will always be patients for whom the prongs do not provide optimal fit. We also recommend cycling regularly between prongs and masks as per our user instructions. The user instructions that accompany the flexitrunk infant interface illustrate the correct interface set-up on the infant, and also state the following checks during use: - "check patient frequently for signs of redness, pressure sores or irritation which may result from extended prong or mask use. We recommend hourly checks. Alternating between mask and prongs can reduce the risk of irritation. Alternating between 4 to 6 hours is recommended. " - "if using mask: the mask should sit comfortably around the patient's nose. " - "set the height of the foam block by adding or removing tear-off strips. Set-ups with masks may require adding strips for proper positioning. " in addition, the user instructions provide step by step instructions with illustrations on the correct set-up, and fitting of the flexitrunk tubing to a nasal mask or prongs.
Patient Sequence No: 1, Text Type: N, H10
[80511230]
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field presentative that the bc3020 flexitrunk infant nasal prongs were causing septal damage for some infants. No further patient consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2017-00654 |
| MDR Report Key | 6727227 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-19 |
| Date of Report | 2017-05-05 |
| Date Mfgr Received | 2017-05-05 |
| Date Added to Maude | 2017-07-19 |
| 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 | MR. IRFANALI KERMALLI |
| 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 PRONGS |
| Generic Name | BZO |
| Product Code | BZO |
| Date Received | 2017-07-19 |
| Model Number | BC3020 |
| Catalog Number | BC3020 |
| Lot Number | NOT PROVIDED |
| 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 | 2017-07-19 |