MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-04 for TUR IRRIGATION SET Y-TYPE 06543 manufactured by Hospira De Costa Rica Ltd..
[347142]
The pt was undergoing surgery for a bladder tumor. The irrigation set was delivering sorbitol via gravity through the surgeon's scope. Reportedly, the tumor was located anterior and "high" in the bladder and the surgeon had to rotate the scope many times. The tubing was reported to disconnect from the scope and the sorbitol solution leaked. The sterile sorbitol solution "sprayed" the surgeon's face. The surgeon was masked and reported to be protected. The set was reconnected to the scope and surgical procedure completed. There was no adverse pt or staff effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2005-00018 |
| MDR Report Key | 573795 |
| Report Source | 05 |
| Date Received | 2005-02-04 |
| Date of Report | 2005-01-06 |
| Date of Event | 2004-12-23 |
| Date Mfgr Received | 2005-01-06 |
| Date Added to Maude | 2005-02-18 |
| 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 | PAUL LANDESMAN, PH.D.,ASST DIR |
| Manufacturer Street | 8401 WEST 102ND STREET DEPT.NO.097U, BLDG.NO.HW1 #300 |
| Manufacturer City | PLEASANT PRAIRIE WI 53158 |
| Manufacturer Country | US |
| Manufacturer Postal | 53158 |
| Manufacturer Phone | 2625776072 |
| Manufacturer G1 | HOSPITA DE COSTA RICA LTD |
| Manufacturer Street | ZONA FRANCA GLOBAL |
| Manufacturer City | LA AURORA DE HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUR IRRIGATION SET Y-TYPE |
| Generic Name | IRRIGATION SET |
| Product Code | EYZ |
| Date Received | 2005-02-04 |
| Model Number | NA |
| Catalog Number | 06543 |
| Lot Number | UNK |
| 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 | 563663 |
| Manufacturer | HOSPIRA DE COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA DE HEREDIA CS |
| Baseline Brand Name | TUR IRRIGATION SET Y-TYPE |
| Baseline Generic Name | IRRIGATION SET |
| Baseline Model No | NA |
| Baseline Catalog No | 06543 |
| Baseline ID | NA |
| Baseline Device Family | SYSTEM, URINE DRAINAGE, CLOSED |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-04 |