MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-06-09 for ACCURUN 1 MULTI-MARKER POSITIVE CONTROL SERIES 6000 A001-6001-P manufactured by Bbi Diagnostics.
[21614584]
Technologist reported eye splash with product. She experienced difficulty snapping open the bullet top tube (the product is manufactured and shipped in a screw topped container, but the laboratory aliquots the product out of this original container into bullet top tubes). When she applied force to snap open the cap, upon opening, droplets of the product splashed into her right eye. Technologist was not wearing protective eyewear. She flushed her eye with water from the laboratory eyewash station. Technologist sought medical evaluation, as the product contains chemically treated hiv and hepatitis positive raw materials. As a precaution, the technologist received anti-hiv prophylaxis. No hepatitis vaccine was administered as she had already been immunized against hepatitis b.
Patient Sequence No: 1, Text Type: D, B5
[21864875]
Since the product was transferred from its original container by the lab, no request was made for return of the product. The product is supplied by the mfr in a vial with a screw cap closure. The lab routinely aliquots the product from its original container to a bullet top tube with a snap top closure. The product labeling includes a safety precaution statement to use universal precautions when handling the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220394-2006-00002 |
| MDR Report Key | 724510 |
| Report Source | 05 |
| Date Received | 2006-06-09 |
| Date of Report | 2006-06-09 |
| Date of Event | 2006-05-19 |
| Date Mfgr Received | 2006-05-19 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2006-06-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBRA PETIT |
| Manufacturer Street | 375 WEST STREET |
| Manufacturer City | WEST BRIDGEWATER MA 02379 |
| Manufacturer Country | US |
| Manufacturer Postal | 02379 |
| Manufacturer Phone | 5085801900 |
| Manufacturer G1 | BBI DIAGNOSTICS |
| Manufacturer Street | 375 WEST STREET |
| Manufacturer City | WEST BRIDGEWATER MA 02379 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02379 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCURUN 1 MULTI-MARKER POSITIVE CONTROL |
| Generic Name | 82MYZ |
| Product Code | MJX |
| Date Received | 2006-06-09 |
| Model Number | SERIES 6000 |
| Catalog Number | A001-6001-P |
| Lot Number | 108904 |
| Device Expiration Date | 2008-03-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DAY |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 713849 |
| Manufacturer | BBI DIAGNOSTICS |
| Manufacturer Address | WEST BRIDGEWATER MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-09 |