MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for ARGYLE 461008E manufactured by Cardinal Health, Inc..
[183895222]
Rn opened 5fr ng tube for placement in nicu patient. Upon inspection for measurement, rn noted that the tube was missing the printed markings on the tube. Tubing and packaging was saved and new tube was obtained and used. The device was never used on patient. It was found prior to use on infant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9847361 |
| MDR Report Key | 9847361 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-27 |
| Report Date | 2020-01-27 |
| Date Reported to FDA | 2020-01-27 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | ARGYLE |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2020-03-18 |
| Model Number | 461008E |
| Catalog Number | 461008E |
| Lot Number | 1824727264 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET BUILDING 5 MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |