MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-10 for GEM CVP (CALIBRATION VALUATION PRODUCT)1 WITH CO-OX 00025000115 manufactured by Instrumentation Laboratory.
[105130767]
A customer reported that their finger was cut when they snapped open a vial of gem cvp1 with co-ox. The cut was minor; the wound was washed and dressed. An instrumentation laboratory (il) representative contacted the facility. The facility verified that protocol was not followed; the operator should have used the ampoule breaker. Instrumentation laboratory's review of the operator's manual and instruction for use sheet confirmed appropriate instruction for the use of the ampoule breaker to snap open the ampoule. No remedial action is required.
Patient Sequence No: 1, Text Type: N, H10
[105130768]
It was reported that a customer cut their finger while snapping open a cvp vial. The customer reported that it was a minor cut. He removed gloves to wash hands with soap and water, then used a bandage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217183-2018-00003 |
| MDR Report Key | 7415356 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-10 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-03-16 |
| Date Mfgr Received | 2018-03-16 |
| Date Added to Maude | 2018-04-10 |
| 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 SHARI O'CONNOR |
| Manufacturer Street | 180 HARTWELL RD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7818614364 |
| Manufacturer G1 | INSTRUMENTATION LABORATORY |
| Manufacturer Street | 180 HARTWELL RD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEM CVP (CALIBRATION VALUATION PRODUCT)1 WITH CO-OX |
| Generic Name | BLOOD GAS QUALITY CONTROL SOLUTION |
| Product Code | JJY |
| Date Received | 2018-04-10 |
| Catalog Number | 00025000115 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTRUMENTATION LABORATORY |
| Manufacturer Address | 180 HARTWELL RD BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-10 |