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 2020-03-25 for CORTRAK ENTERAL ACCESS SYSTEM 20-0950 104720102 manufactured by Avanos Medical Inc..
[184848813]
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. Root cause could not be determined. All information reasonably known as of 24 mar 2020 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). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc. Product is defective or caused serious injury.
Patient Sequence No: 1, Text Type: N, H10
[184848814]
Avanos medical inc. Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients. This is the second of two reports. Refer to 3011270181-2020-00049 for the first report. It was reported by the user facility that "there was 2 lung placements but it was user error... There was no patient injury or pneumothorax to report. " additional information received on 04-mar-2020 indicated that a cortrak device was used; no further details were available. Additional information received on 05-mar-2020 indicated that the device serial numbers were unknown and the device was not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2020-00050 |
| MDR Report Key | 9877401 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-25 |
| 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 GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | CORPAK MEDSYSTEMS, INC. A DIVISION OF HALYARD HLTH |
| Manufacturer Street | 1001 ASBURY DR. |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60089 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORTRAK ENTERAL ACCESS SYSTEM |
| Generic Name | DH CORTRAK (EAS) |
| Product Code | KNT |
| Date Received | 2020-03-25 |
| Model Number | 20-0950 |
| Catalog Number | 104720102 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-25 |