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 2018-07-17 for CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ANTI-IVCONNECTOR 20-9225AIV2 104577200 manufactured by Halyard Health.
[114676654]
The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is not possible as no lot number was provided. Upon completion of the sample evaluation and the investigation; a follow-up report will be filed. All information reasonably known as of 12-jul-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
[114676655]
It was reported the tip of the nasogastric (ng) tube broke off and was inside the patient. There was no reported injuries. Additional information received 29-jun-2018 stated a 5fr corpak ng was placed without stylet (our procedure is to not use the stylet when placing corpak in infants) (b)(6) 2018. On (b)(6) 2018, an x ray was performed due to respiratory distress. The tip of the device was seen separated on x-ray. The tube in place was removed and the tip was not on the tube. The tube appeared to be severed with a very clear cut where the wider part (tip) connected to the narrower part of the ng. The patient excreted the tip of the device on (b)(6) 2018. The patient was reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2018-00024 |
| MDR Report Key | 7695128 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-17 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-06-22 |
| Date Mfgr Received | 2018-10-04 |
| Date Added to Maude | 2018-07-17 |
| 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 WITH ANTI-IVCONNECTOR |
| Generic Name | DH CPK ANTI-IV (AIV) FEEDING TUBES |
| Product Code | FPD |
| Date Received | 2018-07-17 |
| Returned To Mfg | 2018-07-09 |
| Model Number | 20-9225AIV2 |
| Catalog Number | 104577200 |
| Lot Number | UNKNOWN |
| 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 | 2018-07-17 |