MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-30 for BONE MARROW COLLECTION KIT X6R2107 manufactured by Fresenius.
[78815029]
Patient Sequence No: 1, Text Type: N, H10
[78815030]
During a procedure for a bone marrow harvest, a hole was discovered in the filter of the collection kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6680185 |
| MDR Report Key | 6680185 |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-20 |
| Report Date | 2017-06-28 |
| Date Reported to FDA | 2017-06-28 |
| Date Reported to Mfgr | 2017-06-28 |
| Date Added to Maude | 2017-06-30 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | BONE MARROW COLLECTION KIT |
| Generic Name | BONE MARROW COLLECTION/TRANSFUSION KIT |
| Product Code | LWE |
| Date Received | 2017-06-30 |
| Model Number | X6R2107 |
| Catalog Number | X6R2107 |
| Lot Number | FA17A27408 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS |
| Manufacturer Address | 770 COMMONWEALTH DR. WARRENDALE PA 15086 US 15086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-30 |