MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-14 for DELTEC LOGICATH CONVENTIONAL - NEO/PED MXA232X16X40J-NIT manufactured by Smiths Medical Asd, Inc.
[145012997]
The product was not returned by the customer due to contamination. Also no picture was provided. Therefore a complete investigation was not possible. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event.
Patient Sequence No: 1, Text Type: N, H10
[145012998]
It was reported that that during the infusion of solutions into one of the catheter pathways, reflux was observed on the other route. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-02553 |
| MDR Report Key | 8609058 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-14 |
| Date of Report | 2019-08-27 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-07-29 |
| Device Manufacturer Date | 2017-07-08 |
| Date Added to Maude | 2019-05-14 |
| 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 G1 | SMITHS MEDICAL, INTERNATIONAL NIJMEGEN |
| Manufacturer Street | BIJSTERHUIZEN 22 - 08 6604 LD WIJCHEN |
| Manufacturer Country | NL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTEC LOGICATH CONVENTIONAL - NEO/PED |
| Generic Name | CANNULA, CATHETER |
| Product Code | DQR |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-06-19 |
| Catalog Number | MXA232X16X40J-NIT |
| Lot Number | 3468082 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-05-14 |