MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-11-29 for CORFLO NASOGASTRIC/NASOINTESTINAL PEDIATRIC FEEDING TUBE WITH STYLET WTH ANTI-IV 20-8366AIV2 104576801 manufactured by Avanos Medical Inc..
[128756707]
The sample is reported to be available, but has not yet been received by the manufacturer. A review of the device history record is in-progress. All information reasonably known as of 28-nov-2018 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. 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
[128756708]
It was reported that a patient's corflo nasogastric feeding tube came out in the post anesthesia care unit (pacu) and a replacement was attempted with no success. The nasogastric tube (ngt) was placed in the patient on admission for foreign body ingestion and injury to the esophagus. The device had to be replaced in the operating room (or). When preparing for the patient's bath, the registered nurse (rn) noticed that the access port for the patient's ng tube had been removed. It was found on the floor several feet from the crib. It was unknown what caused the issue. The patient was noted to be stable but experienced injury to the esophagus. Again, the injury to esophagus was not caused by the ngt. Additional information received (b)(6) 2018 stated clarifications of the event noting the tube was placed on (b)(6) 2018 at 1526 to the right nare, a 5 fr device was placed in the operating room(or). The device accidently came out in the pacu and was attempted to be replaced in pacu unsuccessfully so it was ultimately replaced in the operating room. The patient would likely require another operating room procedure for replacement of the defective device. It was noted that the hub had become disconnected from the tube on (b)(6) 2018 at 0400. Vital signs and assessment were performed by the healthcare provider. The patient had a large bowel movement which prompted a bath at that time. The rn noticed the access port for the patient's ng tube had been removed. The port was found on the floor several feet from the patient's crib towards the back of the room. The surgical team was contacted on how to proceed regarding replacement of ng tube. The hub was not swallowed according to the notes per the rn documentation. The patient was stable. The device was a critical tube due to the patient ingesting a foreign body and the injury to the esophagus. The patient was scheduled for a procedure in the surgical center or operating room for removal. Additional information received (b)(6) 2018 stated there was no injury to the patient beyond the medical intervention required to replace the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611594-2018-00217 |
| MDR Report Key | 8115413 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-29 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2018-08-13 |
| Date Added to Maude | 2018-11-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 WTH ANTI-IV |
| Generic Name | DH CPK ANTI-IV (AIV) FEEDING TUBES |
| Product Code | FPD |
| Date Received | 2018-11-29 |
| Model Number | 20-8366AIV2 |
| Catalog Number | 104576801 |
| Lot Number | 0002953023 |
| 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 | 2018-11-29 |