MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-10 for COULTER? LYSE SIII DIFF LYTIC REAGENT 8546796 manufactured by Beckman Coulter, Inc..
[15193979]
A customer contacted beckman coulter, inc (bec) to report an event of spill and skin contact with coulter lyse siii diff lytic reagent. The customer indicated that the reagent was spilt onto the countertop while dumping the residual product into the sink. The customer was wearing lab coat, gloves, and eye protection, but the fluid wet through her lab coat and clothing, and onto her skin when she leaned against the sink's counter top. There was no exposure of the fluid to open wounds or mucous membranes. The estimated amount of reagent that spilled was about 30 ml, but the customer was unsure how much reagent she came in contact with. Water was used on her clothing and skin to dilute the reagent. The facility's housekeeping department was contacted for cleanup of the spill. The msds was not reviewed for this event, but the lab has an exposure control plan in place. There was no obvious effect to the customer from the contact with the reagent.
Patient Sequence No: 1, Text Type: D, B5
[15718833]
Service was not dispatched for this event. Root cause for the spill is user error. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01394 |
| MDR Report Key | 2242313 |
| Report Source | 05,06 |
| Date Received | 2011-09-10 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-08-12 |
| Date Mfgr Received | 2011-08-12 |
| Device Manufacturer Date | 2011-03-15 |
| Date Added to Maude | 2011-10-27 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LYSE SIII DIFF LYTIC REAGENT |
| Generic Name | RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2011-09-10 |
| Model Number | LYSE SIII DIFF |
| Catalog Number | 8546796 |
| Lot Number | 101592F |
| Device Expiration Date | 2012-03-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-10 |