MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-20 for SAFEDRAW BLOOD SAMPLING SYSTEM 689069/B manufactured by Merit Medical Singapore Pte Ltd..
| Report Number | 8020616-2019-00099 |
| MDR Report Key | 9098778 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-09-20 |
| Date of Report | 2019-08-26 |
| Date of Event | 2019-08-26 |
| Date Mfgr Received | 2019-10-11 |
| Device Manufacturer Date | 2018-10-16 |
| Date Added to Maude | 2019-09-20 |
| 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 | MRS. KATIE SWENSON, CQE, CBA, CQPA |
| Manufacturer Street | 1600 W MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012081600 |
| Manufacturer G1 | MERIT MEDICAL SINGAPORE PTE LTD. |
| Manufacturer Street | 198 YISHUN AVE 7 |
| Manufacturer City | 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 SYSTEM |
| Generic Name | BLOOD SAMPLING SYSTEM |
| Product Code | DSK |
| Date Received | 2019-09-20 |
| Catalog Number | 689069/B |
| Lot Number | C1446687 |
| 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 768926 SN 768926 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-20 |