MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-01-13 for TUR IRRIGATION SET Y-TYPE 06543 manufactured by Hospira De Costa Rica Ltd..
[17419099]
Report received of a piercing pin that broke during pt use. The pt was undergoing a cystoscopic examination. It was reported the nurse was spiking the port of an irrigation bag, when the tip of the spike broke. Subsequently, the flow of solution carried the broken spike tip fragment through the set tubing to the pt's bladder. The surgeon visualized the fragment and was able to remove the fragment from the bladder. The length of the exam was reportedly prolonged "about 5 minutes. " there was no adverse pt effect. Though requested, no additional info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2005-00010 |
| MDR Report Key | 567625 |
| Report Source | 05 |
| Date Received | 2005-01-13 |
| Date of Report | 2004-12-20 |
| Date of Event | 2004-12-09 |
| Date Mfgr Received | 2004-12-20 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2005-01-27 |
| 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 | 2005-01-13 |
| Returned To Mfg | 2005-05-11 |
| Model Number | NA |
| Catalog Number | 06543 |
| Lot Number | 210285H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 557453 |
| 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 | 2005-01-13 |