MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-09 for PROCLEIX DEACTIVATION BUFFER 303666 manufactured by Hologic, Inc..
[49128902]
(b)(6) operator was splashed in the eye with deactivation fluid. The operator was wearing full ppe including eye protection at the time of the incident. The operator washed her eye for 15 minutes with the emergency eye wash station on-site. Her eye was still stinging, so was taken to the emergency room where she had a 1 hour 'slow drop' saline wash. Fse (field service engineer) visited the (b)(6) to gather information on the incident. The operator had lifted the bottle to her eye level as she attempted to lift it over a system fluid bottle that was at the chest level. The bottle was dropped twice from a short distance of a few inches (once in the instrument and again on the trolley). The lab fully acknowledges that their own procedural actions lead to this event. The bottles failure mode was a drop from height with fluid, not a stress over time failure. The safety data sheet states that tight sealing safety googles should be worn handling deactivation buffer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00019 |
| MDR Report Key | 5780513 |
| Date Received | 2016-07-09 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-06-09 |
| Date Mfgr Received | 2016-06-09 |
| Date Added to Maude | 2016-07-09 |
| 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 | ANILA TARTE |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108055 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROCLEIX DEACTIVATION BUFFER |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JCC |
| Date Received | 2016-07-09 |
| Catalog Number | 303666 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-09 |