MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-19 for S-CAL? CALIBRATOR 179310 manufactured by Beckman Coulter Inc..
[2160992]
The customer reported that on (b)(6) 2011 they observed a leak around the top of a s-cal calibrator vial. At the time the leak was identified the instrument calibration had yielded two outliers and the customer had bleached the system in response to the calibration imprecision. No patient results were involved in this event. The healthcare worker involved in this event was wearing personal protective equipment, which included gloves, at the time of occurrence. No personnel sought medical attention in association with this event. There was no biohazardous exposure to personnel uncovered wounds or mucous membranes and no injuries were reported. No death, injury or modification to patient treatment was associated with this event. There was no exposure control plan in place at the facility.
Patient Sequence No: 1, Text Type: D, B5
[9476346]
Beckman coulter inc. Sent replacement product to the customer. A definitive root cause for this event is unknown at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01467 |
| MDR Report Key | 2253712 |
| Report Source | 05,06 |
| Date Received | 2011-09-19 |
| Date of Report | 2011-08-08 |
| Date of Event | 2011-08-08 |
| Date Mfgr Received | 2011-08-08 |
| Device Manufacturer Date | 2011-07-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S-CAL? CALIBRATOR |
| Generic Name | CALIBRATOR FOR PLATELET COUNTING |
| Product Code | KRY |
| Date Received | 2011-09-19 |
| Model Number | NA |
| Catalog Number | 179310 |
| Lot Number | 1169145F |
| ID Number | NA |
| Device Expiration Date | 2011-08-08 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-09-19 |