MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1996-10-17 for BAXTER IMMUNOTHERAPY 4R2107 manufactured by Baxter Health Care Corp..
[20758042]
Reportedly, during the final filtration into the storage container, the cream colored connector below the clamp separated from the tubing. Approx the last 50cc's of bone marrow cells were lost. The pt was not adversely effected by the event. Sufficient bone marrow had already been captured for the pt. The product will be returned for eval. At the time of this report the product has not been rec'd for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000004-1996-00007 |
| MDR Report Key | 44244 |
| Report Source | 05,07 |
| Date Received | 1996-10-17 |
| Date of Report | 1996-10-16 |
| Date of Event | 1996-09-26 |
| Date Mfgr Received | 1996-09-26 |
| Device Manufacturer Date | 1996-02-01 |
| Date Added to Maude | 1996-10-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAXTER IMMUNOTHERAPY |
| Generic Name | BONE MARROW COLLECTION KIT |
| Product Code | LWE |
| Date Received | 1996-10-17 |
| Model Number | 4R2107 |
| Catalog Number | 4R2107 |
| Lot Number | H96B16460 |
| ID Number | COMPLAINT FILE # 9600133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 45166 |
| Manufacturer | BAXTER HEALTH CARE CORP. |
| Manufacturer Address | HIGHWAY 201 MOUNTAIN HOME AR 72653 US |
| Baseline Brand Name | BONE MARROW COLLECTION KIT |
| Baseline Generic Name | BONE MARROW COLLECTION KIT |
| Baseline Model No | 4R2107 |
| Baseline Catalog No | 4R2107 |
| Baseline ID | NONE |
| Baseline Device Family | BONE MARROW COLLECTION KIT FOR FILTRATION & COLLECTIN OF ASPIRATED BONE MARROW |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K871198 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-17 |