MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-16 for TRANSFER PACK manufactured by Fenwall.
[5873822]
While processing a cellular therapy product, a 600 ml fenwall transfer pack (code: (b)(4) lot: fa14d15079) broke and donor cells leaked out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043181 |
| MDR Report Key | 4859449 |
| Date Received | 2015-06-16 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-02 |
| Date Added to Maude | 2015-06-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSFER PACK |
| Generic Name | TRANSFER PACK |
| Product Code | KSR |
| Date Received | 2015-06-16 |
| Lot Number | FA14D15079 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FENWALL |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-16 |