MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-07 for SAPPHIRE 1634602 manufactured by Hospira, Inc..
[173923944]
Patient was having d10 infusion for low blood sugars. Pre-feed was found to be critically low even after good po (oral) intake. Line was closely inspected, and small hole was found in tubing, causing the iv fluids to leak out prior to reaching patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9557441 |
| MDR Report Key | 9557441 |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-14 |
| Report Date | 2019-12-20 |
| Date Reported to FDA | 2019-12-20 |
| Date Reported to Mfgr | 2020-01-07 |
| Date Added to Maude | 2020-01-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SAPPHIRE |
| Generic Name | ACCESSORIES, PUMP, INFUSION |
| Product Code | MRZ |
| Date Received | 2020-01-07 |
| Model Number | 1634602 |
| Catalog Number | 1634602 |
| Lot Number | 4117418 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA, INC. |
| Manufacturer Address | HIGHWAY 301 NORTH ROCKY MOUNT NC 27801 US 27801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |