MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-15 for BD KIESTRA? INOQULA+? TLA 447213 manufactured by Bd Kiestra Lab Automation.
| Report Number | 3010141591-2019-00166 |
| MDR Report Key | 8899258 |
| Date Received | 2019-08-15 |
| Date of Report | 2019-08-02 |
| Date of Event | 2019-07-18 |
| Date Mfgr Received | 2019-07-18 |
| Device Manufacturer Date | 2018-08-11 |
| Date Added to Maude | 2019-08-15 |
| 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 | BD KIESTRA LAB AUTOMATION |
| Manufacturer Street | 6 MARCONILAAN |
| Manufacturer City | DRACHTEN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1119779-07/23/2019-004-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD KIESTRA? INOQULA+? TLA |
| Generic Name | MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT |
| Product Code | JTC |
| Date Received | 2019-08-15 |
| Catalog Number | 447213 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD KIESTRA LAB AUTOMATION |
| Manufacturer Address | 6 MARCONILAAN DRACHTEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-15 |