MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-27 for SAFEDRAW BLOOD SAMPLING SYSTEM 688351/JPA manufactured by Merit Medical Singapore Pte Ltd..
| Report Number | 8020616-2020-00013 |
| MDR Report Key | 9767422 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2018-07-05 |
| Date Added to Maude | 2020-02-27 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2084551 |
| 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 SYSTEM |
| Generic Name | BLOOD SAMPLING SYSTEM |
| Product Code | DXN |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-22 |
| Catalog Number | 688351/JPA |
| Lot Number | C1357307 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-27 |