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 2020-03-16 for BD MICROTAINER? QUIKHEEL? PREEMIE LANCET 368102 manufactured by Bd Caribe Ltd..
| Report Number | 2618282-2020-00022 |
| MDR Report Key | 9835998 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-04-18 |
| Date Added to Maude | 2020-03-16 |
| 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 CARIBE LTD. |
| Manufacturer Street | ROAD 31 K.M. 24.3 |
| Manufacturer City | JUNCOS |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD MICROTAINER? QUIKHEEL? PREEMIE LANCET |
| Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| Product Code | FMK |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-05 |
| Catalog Number | 368102 |
| Lot Number | 9073635 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD CARIBE LTD. |
| Manufacturer Address | ROAD 31 K.M. 24.3 JUNCOS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |