MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-02-15 for BONE MARROW COLLECTION KIT 4R2107 manufactured by Baxter Healthcare Corp..
[393246]
Technician reported that following bone marrow collection, a small puncture was found in the collection bag. Hole was located at edge of filter tube in the bag. Technician reported that it appeared to have caused the hole. Hospital will take additional sterility procedures (patient given antibiotics) adn bone marrow will not be given back to patient. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420141-2005-00009 |
| MDR Report Key | 577365 |
| Report Source | 04 |
| Date Received | 2005-02-15 |
| Date of Report | 2005-01-10 |
| Date of Event | 2005-01-06 |
| Date Mfgr Received | 2005-01-10 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2005-03-03 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JENNY BAETHKE, MANAGER |
| Manufacturer Street | ROUTE 120 & WILSON ROAD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472706496 |
| Manufacturer G1 | BAXTER HEALTHCARE CORP |
| Manufacturer Street | 1900 HIGHWAY, 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 |
| 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 KIT |
| Product Code | LWE |
| Date Received | 2005-02-15 |
| Model Number | 4R2107 |
| Catalog Number | 4R2107 |
| Lot Number | H02C18509 |
| ID Number | NA |
| Device Expiration Date | 2007-03-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 567204 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | * MOUNTAIN HOME AR * US |
| Baseline Brand Name | BONE MARROW COLLECTION KIT |
| Baseline Generic Name | BONE MARROW COLLECTION KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 4R2107 |
| Baseline Shelf Life [Months] | NA |
| 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 | 2005-02-15 |