MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-08-22 for CRYOCYTE FREEZING CONT. 250 MLW/LABEL POCKET R4R9953 manufactured by Baxter Healthcare.
[931919]
The customer contacted baxter healthcare to report broken cryocyte freezing container. The customer indicated that the cryocyte container was taken from the freezer and placed into a cooler with coolpacks to maintain the container in the vapor phase. The container was then delivered to the intended patient's bedside. The cryocyte was found to be broken when the cooler was opened. The customer indicated that there was no patient impact because there were other containers available to complete the intended dose.
Patient Sequence No: 1, Text Type: D, B5
[8107326]
(b) (4). The sample availability is unknown at this time. If the sample becomes available for evaluation, a follow-up report will be submitted once the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00765 |
| MDR Report Key | 1137883 |
| Report Source | 06 |
| Date Received | 2008-08-22 |
| Date of Report | 2008-08-04 |
| Date of Event | 2008-03-13 |
| Date Mfgr Received | 2008-08-04 |
| Date Added to Maude | 2009-12-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY, MANAGER |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | 1900 HIGHWAY 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653249 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 2497 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOCYTE FREEZING CONT. 250 MLW/LABEL POCKET |
| Generic Name | 81KSE |
| Product Code | KSE |
| Date Received | 2008-08-22 |
| Catalog Number | R4R9953 |
| Lot Number | H07I10011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-22 |