MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1997-06-30 for LIFECELL TISSUE CULTURE FLASK 4R2113 manufactured by Baxter Healthcare Corporation.
[19174303]
Reportedly, a lifecell tissue culture flask leaked while in the incubator. The contents leaked onto 5 other containers in the incubator. The technician indicated that the seal on the tubing of the lifecell tissue culture flask appeared to be incomplete. Cellcor is investigating the sealer as the potential problem. Cells were lost when the leaking container and the 5 possible contaminated containers were discarded, but sufficient product remained for the pts. The pts were not effected by this event. The leaking container has been disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000004-1997-00020 |
| MDR Report Key | 103128 |
| Report Source | 05,07 |
| Date Received | 1997-06-30 |
| Date of Report | 1997-06-27 |
| Date of Event | 1997-06-02 |
| Date Mfgr Received | 1997-06-02 |
| Device Manufacturer Date | 1996-07-01 |
| Date Added to Maude | 1997-07-08 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFECELL TISSUE CULTURE FLASK |
| Generic Name | LIFECELL TISSUE CULTURE FLASK |
| Product Code | KJA |
| Date Received | 1997-06-30 |
| Model Number | 4R2113 |
| Catalog Number | 4R2113 |
| Lot Number | H96G18473 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 101473 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | HIGHWAY 201 MOUNTAIN HOME AR 72653 US |
| Baseline Brand Name | LIFECELL |
| Baseline Generic Name | TISSUE CULTURE FLASK |
| Baseline Model No | 4R2113 |
| Baseline Catalog No | 4R2113 |
| Baseline ID | 3000 ML CAPACIT |
| Baseline Device Family | LIFECELL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K861253 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-30 |