MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2011-08-05 for COULTER? S-CAL HEMATOLOGY CALIBRATOR 624519 manufactured by Beckman Coulter Inc..
[2131034]
It was discovered during the receiving inspection at beckman coulter inc. (bec) and before storing the product into the warehouse that a foreign body (red dot) similar to blood or red ink had adhered to the outside of the coulter s-cal reagent box. It could not be determined if the red spot was blood or ink. Employees were wearing personal protective equipment (ppe) when handling the reagent box. The box was kept in a plastic bag and quarantined as non-conformance. No injuries occurred and medical attention was not sought.
Patient Sequence No: 1, Text Type: D, B5
[9145634]
No additional information is available for this event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01100 |
| MDR Report Key | 2194214 |
| Report Source | 00,01,07 |
| Date Received | 2011-08-05 |
| Date of Report | 2011-07-07 |
| Date of Event | 2011-07-07 |
| Date Mfgr Received | 2011-07-07 |
| Device Manufacturer Date | 2011-06-30 |
| Date Added to Maude | 2012-06-20 |
| 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 AVENUE, |
| 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? S-CAL HEMATOLOGY CALIBRATOR |
| Generic Name | CALIBRATOR FOR PLATELET COUNTING |
| Product Code | KRY |
| Date Received | 2011-08-05 |
| Model Number | NA |
| Catalog Number | 624519 |
| Lot Number | 1158170F |
| Device Expiration Date | 2011-08-08 |
| 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 AVENUE, MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-05 |