MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-12 for IV START KIT DYNDV1815A manufactured by Medline Industries, Inc..
[85796930]
Patient Sequence No: 1, Text Type: N, H10
[85797211]
Rn opened iv start kit and noticed a foreign material which looked like a hair wrapped around tourniquet. No patient contact with product. Manufacturer response for iv start kit, (brand not provided) (per site reporter): equipment failure reported to (b)(4) customer service. Product sent out via (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6858390 |
| MDR Report Key | 6858390 |
| Date Received | 2017-09-12 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-07-12 |
| Report Date | 2017-08-02 |
| Date Reported to FDA | 2017-08-02 |
| Date Reported to Mfgr | 2017-08-02 |
| Date Added to Maude | 2017-09-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV START KIT |
| Generic Name | I.V. START KIT |
| Product Code | LRS |
| Date Received | 2017-09-12 |
| Returned To Mfg | 2017-08-01 |
| Catalog Number | DYNDV1815A |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1204 TOWNLINE RD 1 MEDLINE PLACE MULDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-12 |