MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-04-02 for SANDHILL PRESSURE CAL TUBE S90-5119 NA manufactured by Sandhill Scientific.
[16792957]
Operator used o2 under pressure to dry the inside of the cal tube. When the o2 tubing was placed into the tube, the exit hole of the device was occluded. This caused over pressure of the calibration tube. As a result, the end of the cal tube separated from cyclinder. This flew through the air striking the operator in the face, broke their glasses and knocked them to the floor. Cal tube is not designed for this type of cleaning procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023374-2004-00001 |
| MDR Report Key | 519027 |
| Report Source | 05 |
| Date Received | 2004-04-02 |
| Date of Report | 2004-04-01 |
| Date of Event | 2004-03-26 |
| Date Mfgr Received | 2004-03-26 |
| Date Added to Maude | 2004-04-06 |
| 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 | GUY HARRIS |
| Manufacturer Street | 9150 COMMERCE CENTER CIRCLE #500 |
| Manufacturer City | HIGHLANDS RANCH CO 80129 |
| Manufacturer Country | US |
| Manufacturer Postal | 80129 |
| Manufacturer Phone | 8004684556 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANDHILL PRESSURE CAL TUBE |
| Generic Name | PART NUMBER S90-5119 |
| Product Code | BXY |
| Date Received | 2004-04-02 |
| Model Number | S90-5119 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 508057 |
| Manufacturer | SANDHILL SCIENTIFIC |
| Manufacturer Address | 9150 COMMERCE CENTER CIR.,#500 HIGHLANDS RANCH CO 80129 US |
| Baseline Brand Name | SANDHILL PRESSURE CAL TUBE |
| Baseline Generic Name | PART NUMBER S90-5119 |
| Baseline Model No | S90-5119 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-02 |