MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2018-08-23 for CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ANTI-IV CONNEC 20-9225AIV2 104577200 manufactured by Avanos Medical Inc..
[118108327]
The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is in-progress. Upon completion of the sample evaluation and investigation; a follow-up report will be filed. All information reasonably known as of (b)(6) 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. This product incident is documented in the avanos medical, inc. Complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118108328]
It was reported the tip was coming off of the nasogastric (ng) tube. Additional information received 01-aug-2018 stated the tip of the feeding broke off inside of the patient. Additional information received 08-aug-2018 stated that on (b)(6) 2018 the tube was placed in the right patient's nare, measuring to the 24cm mark. The nurse was unable to obtain aspirate for ph confirmation and a kidneys-urethra-bladder (kub) x-ray confirmed safe gastric placement. The tip of the tube "had come off" in the patients stomach. The patients bowel movements were monitored and the tip was recovered without incident. The was no reported injury or complication from the feeding tube. A medwatch, report number mw5078844, was received on (b)(6) 2018 stating, "rn placed 5 french ng in pt's right nare without difficulty. Rn unable to aspirate to ph confirmation. Rn then requested xray for placement confirmation. Upon review of xray, the tube was found coiled in the esophagus with the free tip broken off in the stomach. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611594-2018-00133 |
| MDR Report Key | 7811322 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2018-08-23 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-07-29 |
| Date Mfgr Received | 2018-09-18 |
| Device Manufacturer Date | 2017-10-18 |
| Date Added to Maude | 2018-08-23 |
| 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 | 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 FEEDING TUBE WITH STYLET WITH ANTI-IV CONNEC |
| Generic Name | DH CPK ANTI-IV (AIV) FEEDING TUBES |
| Product Code | FPD |
| Date Received | 2018-08-23 |
| Returned To Mfg | 2018-08-13 |
| Model Number | 20-9225AIV2 |
| Catalog Number | 104577200 |
| Lot Number | 202808069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-23 |