MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-14 for TRUCOLOR WRIGHT'S GIEMSA STAIN 7547178 manufactured by Beckman Coulter, Inc..
[2174916]
A customer reported that while executing product receiving activities on (b)(6) 2011 they observed two bottles of trucolor wright's giemsa stain leaking (volume unknown) inside their clear plastic bag. There was no human contact with the fluid. No one was splashed or sprayed. The healthcare worker interfacing with the stain was wearing personal protective equipment, which included gloves, eye protection and a laboratory coat, at the time of occurrence. There was no biohazardous exposure to healthcare worker uncovered wounds or mucous membranes and no injury was reported. No personnel sought any medical attention in association with this event. No patient results were affected by this event. No death, injury or modification to patient treatment was associated with this event. There was an exposure plan in place at the facility and the material safety data sheet was available.
Patient Sequence No: 1, Text Type: D, B5
[9390654]
Service was not dispatched to the site for this event. Beckman coulter inc. Requested product evaluation information from the customer. Specifically, no physical damage was observed to the outside of the boxes in which the bottles were packed. The customer declined to inspect the stain bottle caps. A definitive root cause for this event has not been determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01426 |
| MDR Report Key | 2247464 |
| Report Source | 06 |
| Date Received | 2011-09-14 |
| Date of Report | 2011-08-16 |
| Date of Event | 2011-08-16 |
| Date Mfgr Received | 2011-08-16 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-06-26 |
| 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 KEAMER 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 AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUCOLOR WRIGHT'S GIEMSA STAIN |
| Generic Name | STAINS, HEMATOLOGY |
| Product Code | KQC |
| Date Received | 2011-09-14 |
| Model Number | NA |
| Catalog Number | 7547178 |
| Lot Number | 0625310 |
| ID Number | NA |
| Device Expiration Date | 2012-09-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-14 |