MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-27 for IV START KIT MICRO DYND1905A manufactured by Medline Industries Inc..
Report Number | 8739078 |
MDR Report Key | 8739078 |
Date Received | 2019-06-27 |
Date of Report | 2019-06-24 |
Date of Event | 2019-06-20 |
Report Date | 2019-06-24 |
Date Reported to FDA | 2019-06-24 |
Date Reported to Mfgr | 2019-06-27 |
Date Added to Maude | 2019-06-27 |
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 |
Reporter Occupation | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | IV START KIT MICRO |
Generic Name | KIT, IV START |
Product Code | LRS |
Date Received | 2019-06-27 |
Catalog Number | DYND1905A |
Lot Number | 19DBL769 |
Device Availability | Y |
Device Age | 1 DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDLINE INDUSTRIES INC. |
Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-06-27 |