MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for CONTAINER, EMPTY, FOR COLLECTION AND PROCESSING OF BLOOD AND BLOOD PRODUCTS manufactured by Fenwal.
[105386707]
Fenwal's anticoagulant sodium citrate solution usp and anticoagulant citrate dextrose solution usp (acd) formula a bags look very similar and can easily be mistaken for one another. Previously, pharmacy technicians have mistakenly restocked one for the other in the automatic dispensing cabinets but the mistake was caught prior to administration to the patient. Fenwal should change the label of these two bags to prevent future mistakes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076428 |
| MDR Report Key | 7424839 |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-10 |
| Date Added to Maude | 2018-04-12 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 | CONTAINER, EMPTY, FOR COLLECTION AND PROCESSING OF BLOOD AND BLOOD PRODUCTS |
| Generic Name | CONTAINER, EMPTY, FOR COLLECTION AND PROCESSING OF BLOOD AND BLOOD PRODUCTS |
| Product Code | KSR |
| Date Received | 2018-04-11 |
| Lot Number | Y236737 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FENWAL |
| Brand Name | CONTAINER, EMPTY, FOR COLLECTION AND PROCESSING OF BLOOD AND BLOOD PRODUCTS |
| Generic Name | CONTAINER, EMPTY, FOR COLLECTION AND PROCESSING OF BLOOD AND BLOOD PRODUCTS |
| Product Code | KSR |
| Date Received | 2018-04-11 |
| Lot Number | Y251769 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | FENWAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-11 |