MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-05 for RED BLOOD CELL FREEZING PACK 4R2422 manufactured by .
[1626470]
During glycerolization process at our facility, we discovered a slit near the seam on fenwal 2l bag with product code (b)(4) and lot # fa09j08046. During the 2nd phase of washing and concentration of ct product, we discovered leaks near the seam on fenwal 2l bag with product code (b)(4) and lot # fa10b19079.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017024 |
| MDR Report Key | 1793625 |
| Date Received | 2010-08-05 |
| Date of Report | 2010-08-05 |
| Date of Event | 2010-07-26 |
| Date Added to Maude | 2010-08-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | RED BLOOD CELL FREEZING PACK |
| Generic Name | RED BLOOD CELL FREEZING PACK |
| Product Code | KSE |
| Date Received | 2010-08-05 |
| Catalog Number | 4R2422 |
| Lot Number | FA09J08046 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Brand Name | RED BLOOD CELL FREEZING PACK |
| Generic Name | RED BLOOD CELL FREEZING PACK |
| Product Code | KSE |
| Date Received | 2010-08-05 |
| Catalog Number | 4R2422 |
| Lot Number | FA10B19079 |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-05 |