MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2011-12-15 for COULTER TRUCOLOR WRIGHT GIEMSA STAIN 7547178 manufactured by Beckman Coulter, Inc..
[2369387]
A beckman coulter, inc. (bec) employee reported that the coulter trucolor wright giemsa stain, lot #0625310, was leaking a small amount of stain around its cap. Initially, the seal around the cap had a small area of blue discoloration; but upon being set in an upright position, the entire seal became blue and evidence of the stain was found on the outside of the bottle. The bec employee observed this phenomenon with all four bottles of 2-liter stain; however, none of the 50-milliliter bottles presented this issue. The bec employee stated that no one was exposed to or affected by the leak.
Patient Sequence No: 1, Text Type: D, B5
[9557554]
The leak was discovered by a beckman coulter, inc. (bec) employee in hardware development department of bec. The root cause of the leak is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02673 |
| MDR Report Key | 2378078 |
| Report Source | 00,07 |
| Date Received | 2011-12-15 |
| Date of Report | 2011-11-16 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2011-11-16 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-07-24 |
| 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 | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER TRUCOLOR WRIGHT GIEMSA STAIN |
| Generic Name | GIEMSA STAIN |
| Product Code | HYF |
| Date Received | 2011-12-15 |
| Model Number | GIEMSA STAIN |
| Catalog Number | 7547178 |
| Lot Number | 0625310 |
| Device Expiration Date | 2012-09-01 |
| Operator | OTHER |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-15 |