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 2018-08-30 for CORFLO NASOGASTRIC/NASOINTESTINAL PEDIATRIC FEEDING TUBE WITH STYLET, ANTI-IV 20-8366AIV2 104576801 manufactured by Avanos Medical Inc..
[118868507]
The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 30-aug-2018 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by avanos medical, inc. Represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc. Avanos medical, inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118868508]
It was reported there were an unspecified number lung placements that occurred. The value analysis nurse at facility believed that the lung placements were not caused by the product; it is believed the cause was user error each time. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611594-2018-00143 |
| MDR Report Key | 7836208 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-30 |
| Date of Report | 2018-11-26 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2018-08-30 |
| 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. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT SA DE R.L. DE C.V. (AVENT 1) |
| Manufacturer Street | CIRCUITO INDUSTIAL NO.40 COLONIA OBRERA |
| Manufacturer City | NOGALES, CP |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORFLO NASOGASTRIC/NASOINTESTINAL PEDIATRIC FEEDING TUBE WITH STYLET, ANTI-IV |
| Generic Name | DH CPK ANTI-IV (AIV) FEEDING TUBES |
| Product Code | FPD |
| Date Received | 2018-08-30 |
| Model Number | 20-8366AIV2 |
| Catalog Number | 104576801 |
| Lot Number | ANP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-30 |