MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for LTXFR CYSTOSCOPY IRR 654401 065440403 manufactured by Icu Medical Costa Rica Ltd..
[186804317]
The device has been received for evaluation. Testing is not complete.
Patient Sequence No: 1, Text Type: N, H10
[186804318]
The event involved a ltxfr cystoscopy irr where the prong of the continuous bladder irrigation tubing set broke off after the bag was spiked and the prong was seen floating in the fluid of the bag. There was patient involvement, but the broken prong was noticed and the tubing or bag changed out before it reached the patient. There were no fragments passing through the tubing set. There was no adverse event, no delay in critical therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2020-00048 |
| MDR Report Key | 9880194 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTOPHER ZANONI |
| Manufacturer Street | 600 N. FIELD DR. |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2247062300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LTXFR CYSTOSCOPY IRR |
| Generic Name | CATHETER, IRRIGATION |
| Product Code | GBX |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 654401 |
| Catalog Number | 065440403 |
| Lot Number | 4102714 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |