MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-21 for IV START KIT * DYNDBARD8 manufactured by Medline Industries , Inc..
[5298681]
During a scheduled infusion therapy and setup by the nurse (rn), an intravenous line (iv) was started and the rn attempted to insert the connector tubing with the clave attachment. While attempting a saline flush, the clinician noted a leakage at catheter hub between the microclave and the extension set. The clinician changed to a new set and the same leakage occurred. The leakage occurred between the assembled microclave and the 4" extension set. After the second leaking hub, the clinician removed all iv start kits with same lot number for biomedical evaluation and return to the manufacturer. The rn indicated they have been checking the tightness of the clave connector to the extension tube and still have had issues with leaking solution at the hub interface. This is a recurring failure on the same device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4283255 |
| MDR Report Key | 4283255 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-11-21 |
| Date of Event | 2014-11-17 |
| Report Date | 2014-11-21 |
| Date Reported to FDA | 2014-11-21 |
| Date Reported to Mfgr | 2014-11-28 |
| Date Added to Maude | 2014-11-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV START KIT |
| Generic Name | IV START KIT |
| Product Code | LRS |
| Date Received | 2014-11-21 |
| Model Number | * |
| Catalog Number | DYNDBARD8 |
| Lot Number | 14GB1144 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DAY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES , INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-21 |