MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-19 for NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 12F LOCKING PIGTAIL NOD12LPT manufactured by Bard Access Systems.
[127864879]
As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Patient Sequence No: 1, Text Type: N, H10
[127864880]
It was reported that the connection part of the catheter was broken and leakage was found. The device was removed and replaced. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-03291 |
| MDR Report Key | 8087948 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-11-19 |
| 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 | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 12F LOCKING PIGTAIL |
| Generic Name | STAND, INFUSION |
| Product Code | FOX |
| Date Received | 2018-11-19 |
| Catalog Number | NOD12LPT |
| Lot Number | GFCQ0841 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-19 |