MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for HUMMI MICRO DRAW TRANSFER DEVICE ABG-HM-1 manufactured by Hummingbird Med Devices Inc.
[180583039]
Hummi micro-draw blood transfer device used to obtain blood gas reported to be defective with leak/crack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9745208 |
| MDR Report Key | 9745208 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-01 |
| Report Date | 2020-01-06 |
| Date Reported to FDA | 2020-01-06 |
| Date Reported to Mfgr | 2020-02-24 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMMI MICRO DRAW TRANSFER DEVICE |
| Generic Name | SYSTEM, BLOOD COLLECTION |
| Product Code | KST |
| Date Received | 2020-02-24 |
| Catalog Number | ABG-HM-1 |
| Lot Number | 19129 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUMMINGBIRD MED DEVICES INC |
| Manufacturer Address | 1283 ELGER BAY ROAD STE D CAMANO ISLAND WA 98282 US 98282 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |