MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for LOGICATH? CATHETER MXA232X16X40J-NIT manufactured by Smiths Medical Asd, Inc..
[113945875]
Investigation was performed on a smiths medical catheter. No failure was detected when dhr was performed. No actual device was returned, however customer did provide photographs. According to the provided pictures a damage or deviation on the catheter delta cannot be determined. No picture of the suture wing and clip was provided and therefore it is unknown if the suture wing and clip was used to fix the catheter. Within the ifu for the logicath single and multiple lumen cvcs 004/009/104a there is exactly written how to fix the catheter safely. On the one hand it is described how to fix the catheter with the delta. On the other hand it's also mentioned how to fix the cvc with the help of the moveable suture wing and clip. Based on the above information it is felt that this incident is not due to a product failure of the catheter. The reported failure could not be confirmed with the provided pictures and missing sample.
Patient Sequence No: 1, Text Type: N, H10
[113945876]
Information was received that a smiths medical central venous catheter was difficult to place. This happened during testing of the device. No patient injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-02772 |
| MDR Report Key | 7679197 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-06-13 |
| Date Added to Maude | 2018-07-11 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | BRETONISCHER RING 3 |
| Manufacturer City | GRASBRUNN, 85630 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 85630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LOGICATH? CATHETER |
| Generic Name | CANNULA, CATHETER |
| Product Code | DQR |
| Date Received | 2018-07-11 |
| Returned To Mfg | 2018-06-26 |
| Catalog Number | MXA232X16X40J-NIT |
| Lot Number | 3422810 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-11 |