MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2012-04-13 for S-CAL HEMATOLOGY CALIBRATOR N/A 624519 manufactured by Beckman Coulter Inc..
[15210202]
An internal beckman coulter employee reported the s-cal hematology calibrator package was received with a reddish smudge on the package insert and the vial label. The employee stated that the package was intact and the vials were sealed. The employee was wearing personal protective equipment consisting of a lab coat, gloves and eye protection during the event and no injury or exposure was reported. The root cause for the reddish smear on the package insert and vial is unknown.
Patient Sequence No: 1, Text Type: D, B5
[15751464]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01211 |
| MDR Report Key | 2535384 |
| Report Source | 01,06,07 |
| Date Received | 2012-04-13 |
| Date of Report | 2012-03-22 |
| Date of Event | 2012-03-22 |
| Date Mfgr Received | 2012-03-22 |
| Device Manufacturer Date | 2012-03-09 |
| Date Added to Maude | 2012-09-11 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 | S-CAL HEMATOLOGY CALIBRATOR |
| Generic Name | CALIBRATOR FOR PLATELET COUNTING |
| Product Code | KRY |
| Date Received | 2012-04-13 |
| Model Number | N/A |
| Catalog Number | 624519 |
| Lot Number | 1158207F |
| Device Expiration Date | 2012-04-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-13 |