MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-24 for ULTRASAFE X100L PNG CLEAR SECURE TAB 47450030 manufactured by Becton Dickinson Hungary Kft (bd).
| Report Number | 3009081593-2020-00020 |
| MDR Report Key | 9745289 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-07-31 |
| Date Added to Maude | 2020-02-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON HUNGARY KFT (BD) |
| Manufacturer Street | UVEGGYAR UTCA 3 |
| Manufacturer City | KORNYE TATABANYA 2851 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 2851 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASAFE X100L PNG CLEAR SECURE TAB |
| Generic Name | PISTON SYRINGE |
| Product Code | MEG |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-10 |
| Catalog Number | 47450030 |
| Lot Number | 9212009 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON HUNGARY KFT (BD) |
| Manufacturer Address | UVEGGYAR UTCA 3 KORNYE TATABANYA 2851 HU 2851 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-24 |