MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-12 for CARDIAC ANGIOGRAM DIAGNOSTIC PACK SAN14DRRGY manufactured by Cardinal Health.
[38423939]
Manifold was prepared in the usual fashion, connections checked and contrast was primed. After tig catheter insertion, manifold was connected by md and flushed. Two pictures were taken and on the third picture it was noted that there was air emboli in the circumflex.. The patient rapidly decompensated angiodynamics supplies the manifold to cardinal for assembly, and then re-packed in the information provided. Angiodynamics information is lot 4924376 with catalog number 651800217 with expiration date of 05/01/2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060195 |
| MDR Report Key | 5440585 |
| Date Received | 2016-02-12 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-01-28 |
| Date Added to Maude | 2016-02-17 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | CARDIAC ANGIOGRAM DIAGNOSTIC PACK |
| Generic Name | PURPLE PACK |
| Product Code | OEQ |
| Date Received | 2016-02-12 |
| Catalog Number | SAN14DRRGY |
| Lot Number | 427875 |
| Device Expiration Date | 2017-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-02-12 |