MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for FEEDING TUBE VALVE manufactured by Icu Medical Inc.
[185707446]
New cortrak 10 fr feeding tube inserted into this pt. The valve did not fit securely into the feeding tube and would not stay connected to the feeding tube, so nurse was unable to give meds or feeding through this as usual. The valve changed to lot number 4142426, and this one did stay secured and was able to be used as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902926 |
| MDR Report Key | 9902926 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-13 |
| Report Date | 2020-02-19 |
| Date Reported to FDA | 2020-02-19 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEEDING TUBE VALVE |
| Generic Name | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
| Product Code | KNT |
| Date Received | 2020-03-31 |
| Lot Number | 4130737 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL INC |
| Manufacturer Address | 4455 ATHERTON DR SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |