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 2018-06-29 for CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET W/ ANTI-IV CONNECTOR 20-7431AIV2 104575800 manufactured by Halyard Health.
[113015129]
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 halyard health 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 halyard health. Halyard health 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 halyard health complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[113015150]
Halyard received a single report that referenced two different incidents, which were associated with separate units, involving an unknown number of patients. This is the second of two reports. Refer to 3011270181-2018-00021 for the first event. It was reported that a dobhoff feeding tube was inserted, and placement was confirmed. When the nurse started to use the feeding tube, the medication expelled out of a slit/hole in the tubing. The feeding tube was removed and saved. Additional information received stated that the slit was located in the nasal area. The centimeters were not marked, but it was noted that the nasal area is usually around 65 cm. Fda user facility report # 3600840000-2018-8015 was received on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2018-00022 |
| MDR Report Key | 7652840 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-29 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-05-17 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2017-06-19 |
| Date Added to Maude | 2018-06-29 |
| 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 |
| 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 HAYLARD 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 | CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET W/ ANTI-IV CONNECTOR |
| Generic Name | DH CPK ANTI-IV (AIV) FEEDING TUBES |
| Product Code | FPD |
| Date Received | 2018-06-29 |
| Returned To Mfg | 2018-06-26 |
| Model Number | 20-7431AIV2 |
| Catalog Number | 104575800 |
| Lot Number | 78691 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |