MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-01-25 for NV LARGE BORE Y-IRRIGATION SET 06599 manufactured by Hospira De Costa Rica Ltd..
[347162]
Patient was undergoing a transurethral resection of the prostate. The customer reported that 3l glycine bags were being consecutively spiked and replaced by the circulating nurse while glycine was delivered via gravity. Their routine is to change bags, open the flow wide open, clamp off the empty line, and spike the next bag. After changing bag number 0 or 10, the surgeon visualized a foreign fragment, and was able to remove it from the bladder without significant delay. Subsequently, the fragment was matched up with a broken section in the piercing pin tip area. There was no adverse patient effect.
Patient Sequence No: 1, Text Type: D, B5
[6316502]
Patient was undergoing a transurethral resection of the prostate. The customer reported that 3l glycine bags were being consecutively spiked and replaced by the circulating nurse while glycine was delivered via gravity. Their routine is to change bags, open the flow wide open, clamp off the empty line, and spike the next bag. After changing bag number 9 or 10, the surgeon visualized a foreign fragment, and was able to remove it from the bladder without significant delay. Subsequently, the fragment was matched up with a broken section in the piercing pin tip area. There was no adverse patient effect.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 9615050-2005-00014 |
| MDR Report Key | 571155 |
| Report Source | 05 |
| Date Received | 2005-01-25 |
| Date of Report | 2005-01-04 |
| Date of Event | 2005-01-04 |
| Date Mfgr Received | 2005-01-04 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2005-02-09 |
| 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 SUITE 300 |
| Manufacturer City | PLEASANT PRAIRIE WI 53158 |
| Manufacturer Country | US |
| Manufacturer Postal | 53158 |
| Manufacturer Phone | 2625776072 |
| Manufacturer G1 | HOSPIRA 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 | NV LARGE BORE Y-IRRIGATION SET |
| Generic Name | IRRIGATION SET |
| Product Code | EYN |
| Date Received | 2005-01-25 |
| Returned To Mfg | 2005-01-06 |
| Model Number | NA |
| Catalog Number | 06599 |
| Lot Number | 201295H |
| 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 | 561005 |
| Manufacturer | HOSPIRA DE COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA DE HEREDIA CS |
| Baseline Brand Name | NV LARGE BORE Y-IRRIGATION SET |
| Baseline Generic Name | IRRIGATION SET |
| Baseline Catalog No | 06599 |
| Baseline ID | NA |
| Baseline Device Family | TRAY, IRRIGATION, STERILE |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K841362 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-25 |
| 2 | 0 | 2005-01-25 |