MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-10-10 for SAFEDRAW BLOOD SAMPLING SET 686304/B manufactured by Merit Medical Singapore Pte Ltd..
| Report Number | 8020616-2019-00117 |
| MDR Report Key | 9176879 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-10-10 |
| Date of Report | 2019-09-17 |
| Date of Event | 2019-09-17 |
| Date Mfgr Received | 2019-10-25 |
| Device Manufacturer Date | 2018-11-25 |
| Date Added to Maude | 2019-10-10 |
| 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 | MR. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| Manufacturer G1 | MERIT MEDICAL SINGAPORE PTE LTD. |
| Manufacturer Street | 198 YISHUN AVE 7 |
| Manufacturer City | SINGAPORE, 768926 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 768926 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFEDRAW BLOOD SAMPLING SET |
| Generic Name | BLOOD SAMPLING SET |
| Product Code | DSK |
| Date Received | 2019-10-10 |
| Catalog Number | 686304/B |
| Lot Number | C1461994 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SINGAPORE PTE LTD. |
| Manufacturer Address | 198 YISHUN AVE 7 SINGAPORE, 768926 SN 768926 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-10 |