MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-10 for IV START KIT DYNDV1614 manufactured by Medline Industries, Inc..
[3779573]
While injecting contrast via a power infuser, the extension tubing burst and the iv had to be restarted.
Patient Sequence No: 1, Text Type: D, B5
[11116904]
During a radiology procedure, contrast media was injected via a power infuser into the iv extension tubing. The tubing burst and the iv site had to be restarted. This iv extension set is a component in a custom kit and is manufactured by carefusion. They have been notified of this incident. The device is not power injector rated. We have not had any other similar incidents reported to us for this device. There was no injury to the patient but in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00075 |
| MDR Report Key | 3413831 |
| Report Source | 05,06 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-10-09 |
| Date of Event | 2013-09-09 |
| Date Mfgr Received | 2013-09-10 |
| Date Added to Maude | 2013-10-17 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV START KIT |
| Product Code | LRS |
| Date Received | 2013-10-10 |
| Catalog Number | DYNDV1614 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-10 |