MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-20 for LIQUICHEK BLOOD GAS EGL CONTROL 511 manufactured by Bio-rad Laboratories, Inc.
[103282202]
Liquichek blood gas plus egl control is not manufactured from a biological source material. This product is a buffered bicarbonate and electrolyte solution and contains no constituents of human or animal material.
Patient Sequence No: 1, Text Type: N, H10
[103282203]
The coordinating analyst contacted bio-rad to report a finger cut involving liquichek blood gas plus egl control, lot 29510. The lab technician cut a finger when breaking an ampule to open it prior to running on an analyzer. The technician received care by the hospital's emergency team. The incident occurred in the hospital laboratory. The technician wa not wearing gloves or using an ampule breaker.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2018-00002 |
| MDR Report Key | 7355467 |
| Date Received | 2018-03-20 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2018-02-26 |
| Device Manufacturer Date | 2015-12-31 |
| Date Added to Maude | 2018-03-20 |
| 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 | MS MARIA ZEBALLOS |
| Manufacturer Street | 9500 JERONIMO RD. |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIQUICHEK BLOOD GAS EGL CONTROL |
| Generic Name | CONTROLS FOR BLOOD-GASES (ASSAYED AND UNASSAYED) |
| Product Code | JJS |
| Date Received | 2018-03-20 |
| Catalog Number | 511 |
| Lot Number | 29510 |
| Device Expiration Date | 2018-12-31 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC |
| Manufacturer Address | 9500 JERONIMO RD IRVINE CA 926182017 US 926182017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-20 |