MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-24 for CHARTER MEDICAL CRYOBAG manufactured by Charter Medical.
[73825778]
It was reported that during thaw of a patient product, the bag integrity was compromised, accounting for an approximate 10ml loss of an 80ml product. The bag was removed to the bmt cell therapy lab for recovery. Investigation of the break showed the seam between the port and the bag broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069315 |
| MDR Report Key | 6521803 |
| Date Received | 2017-04-24 |
| Date of Report | 2017-04-24 |
| Date of Event | 2017-04-20 |
| Date Added to Maude | 2017-04-26 |
| 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 | ATTORNEY |
| 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 | CHARTER MEDICAL CRYOBAG |
| Generic Name | CRYOBAG STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2017-04-24 |
| Lot Number | 142707 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHARTER MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-24 |