MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-04-28 for ACCURUN 1 MULTI-MARKER POSITIVE CONTROL SERIES 4400 A001-4408-P manufactured by Bbi Diagnostics.
[456600]
Technologist report eye splash with product. She experienced difficulty removing the push and pull cap from a vial of the product (the product is manufactured and shipped with a screw cap, but the laboratory replaced the screw cap with a push and pull cap). When she applied forceto the cap, a drop of product on the cap splashed into her left eye. Technologist was not wearing protective eyewear and was wearing contact lenses. She removed her contact lens and flushed her eye with water for approximately 10 minutes. Technologist was referred to the hospital's outpaient infectious disease service for follow-up medical evaluation, as the product contains chemically treated hiv and hepatitis positive raw materials. As a precaution, the technologist received anti-hiv prohylaxis and a hepatitis b vaccine, although the risk of infection was felt to be low.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220394-2006-00001 |
| MDR Report Key | 707895 |
| Report Source | 05 |
| Date Received | 2006-04-28 |
| Date of Report | 2006-04-28 |
| Date of Event | 2006-04-11 |
| Date Mfgr Received | 2006-04-11 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2006-05-05 |
| 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 | 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, A SERACARE COMPANY |
| 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 | 2006-04-28 |
| Model Number | SERIES 4400 |
| Catalog Number | A001-4408-P |
| Lot Number | 109744 |
| ID Number | * |
| Device Expiration Date | 2008-09-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 696946 |
| Manufacturer | BBI DIAGNOSTICS |
| Manufacturer Address | * WEST BRIDGEWATER MA * US |
| Baseline Brand Name | ACCURUN1 MULTI-MARKER POSITIVE CONTROL |
| Baseline Generic Name | 82MYZ |
| Baseline Model No | SERIES 4400 |
| Baseline Catalog No | A00-4408 P |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-28 |