MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-23 for MILTENYI CLINIMACS CD34+ SELECTION SYSTEM manufactured by Miltenyi.
[78578120]
The cd34 selection took place efficiently, however products were cryopreserved in vials. The cryopreserved vials for pbsc and lymphocytes for pt to be transplanted on (b)(6) 2017 appear to have been partially unscrewed (2 rungs) likely due to vial overfilling. No product spillage occurred into the sterile bag covers in which the products were placed. Consequently, no cell loss appears to have occurred and the vials appear full, however, this medwatch is being reported because a potential breach of sterility and potential loss of cells.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070646 |
| MDR Report Key | 6669586 |
| Date Received | 2017-06-23 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-06-20 |
| Date Added to Maude | 2017-06-27 |
| 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 | MILTENYI CLINIMACS CD34+ SELECTION SYSTEM |
| Generic Name | MAGNETIC CELL SELECTION SYSTEM FOR CD34+ CELLS |
| Product Code | OVG |
| Date Received | 2017-06-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-23 |