MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-08-12 for RED CELL LYSING REAGENT ACT 5 DIFF WBC LYSE 8547170 manufactured by Beckman Coulter Inc..
[19651879]
No apparent shipping damage was noted. Service was not dispatched. Root cause is unknown for this event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19846735]
A beckman coulter inc. (bec) operator reported receiving bottle of act 5 diff wbc lyse bottle which had leaked form the bottom causing damage to six other bottle labels. The operator was wearing gloved at the time of the incident. No exposure, or contact with the eyes or skin, open wounds or mucous membranes. The msds was reviewed and there is an exposure control / risk management plan in place at the facility. No death, injury or change to patient treatment attributed or associated to this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2011-01175 |
| MDR Report Key | 2210826 |
| Report Source | 01,07 |
| Date Received | 2011-08-12 |
| Date of Report | 2011-07-13 |
| Date of Event | 2011-07-13 |
| Date Mfgr Received | 2011-07-13 |
| Device Manufacturer Date | 2012-02-21 |
| Date Added to Maude | 2012-06-21 |
| 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 BVLD |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RED CELL LYSING REAGENT |
| Generic Name | RED CELL LYSING REAGENT. |
| Product Code | GGK |
| Date Received | 2011-08-12 |
| Model Number | ACT 5 DIFF WBC LYSE |
| Catalog Number | 8547170 |
| Lot Number | 15202B |
| ID Number | N/A |
| Device Expiration Date | 2011-02-21 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-08-12 |