MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for AQUILEX TUBE SET FOR IRRIGATION AQL-110 manufactured by W.o.m. World Of Medicine Usa, Inc.
[185520990]
Hooked irrigation bags to tubing threaded tubing through pump. Turned on pump. Pump said to remove tubing for system check. Removed tubing, system check completed = ok. Rethreaded tubing into pump. Started to prime tubing. Water came spraying out from where its threaded through pump. Stopped pump and changed out tubing. Rethreaded and primed without issue. First tubing noted to have a pin hole in bladder of squared chipped plastic piece, where fluid was leaking out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897328 |
| MDR Report Key | 9897328 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-14 |
| Report Date | 2020-03-23 |
| Date Reported to FDA | 2020-03-23 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUILEX TUBE SET FOR IRRIGATION |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC |
| Product Code | HIG |
| Date Received | 2020-03-30 |
| Model Number | AQL-110 |
| Catalog Number | AQL-110 |
| Lot Number | K18N385 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.O.M. WORLD OF MEDICINE USA, INC |
| Manufacturer Address | 4531 36TH ST. ORLANDO FL 32811 US 32811 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |