MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-02 for BLAKEMORE TUBE, 3 LUMEN, 21 FR 36" 21FR 36" 2300-21 manufactured by Rusch, Inc..
[18145]
Device was needed for a critically ill pt in an intensive care unit. The first two tubing sets were taken from the storage area and it was found that the latex balloons had deteriorated in the package. The third set was used on the pt. The third set was in good condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026041 |
| MDR Report Key | 27783 |
| Date Received | 1995-11-02 |
| Date Added to Maude | 1995-11-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAKEMORE TUBE, 3 LUMEN, 21 FR 36" |
| Generic Name | BLAKEMORE TUBE |
| Product Code | FEF |
| Date Received | 1995-11-02 |
| Model Number | 21FR 36" |
| Catalog Number | 2300-21 |
| Lot Number | BATCH # E313225 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 28681 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY DULUTH GA 30136 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-11-02 |