MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for URESIL GENERAL PURPOSE LOCKING DRAINAGE CATHETER GPL2-1030H manufactured by Uresil Llc.
[174671343]
Drainage catheter had pinhole in hub that couldn't hold suction. Abscess tube placement in ct scan, tube placed and when suction bulb was attached to catheter it was noticed that the suction bulb was loosing suction. Connections were checked, it was discovered that the drainage catheter was the cause of the loss of suction. A new catheter needed to be placed. Pinhole was confirmed by inserting fluid through the explanted catheter while occluding the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092109 |
| MDR Report Key | 9569266 |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-10 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | URESIL GENERAL PURPOSE LOCKING DRAINAGE CATHETER |
| Generic Name | CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY |
| Product Code | GBO |
| Date Received | 2020-01-08 |
| Model Number | GPL2-1030H |
| Catalog Number | GPL2-1030H |
| Lot Number | 9F453 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | URESIL LLC |
| Manufacturer Address | 5418 W TOUHY AVE SKOKIE IL 60077 US 60077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |