MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-04 for COULTER S-CAL CALIBRATOR 624519 manufactured by Beckman Coulter, Inc..
[18503384]
The customer reported an s-cal calibrator vial leaking while mixing and the s-cal cap came off the container. The operator was wearing gloves and laboratory scrub clothing. The calibrator spilled on the floor, the counter and the cabinet doors and on the front of the customer's scrubs and pant legs. The customer went home to change clothes then had her blood drawn for potential biohazard exposure testing. The customer stated that she received the calibrator from another facility. The other facility used one vial of calibrator and sent the remaining via to her. The customer did not initially observe any leaks from the calibrator. There was no exposure of potential biohazard to mucous membranes or to open lesions.
Patient Sequence No: 1, Text Type: D, B5
[18741968]
This reportable event was identified during a retrospective review conducted for the period between 01/01/2008 and 10/23/2010 of complaints for additional reportable events. Product was replaced at the time of the event. Based upon available info the root cause is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02065 |
| MDR Report Key | 2339993 |
| Report Source | 05,06 |
| Date Received | 2011-11-04 |
| Date of Report | 2009-10-01 |
| Date of Event | 2009-10-01 |
| Date Mfgr Received | 2009-10-01 |
| Date Added to Maude | 2012-07-12 |
| 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. 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 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 S-CAL CALIBRATOR |
| Product Code | KRY |
| Date Received | 2011-11-04 |
| Model Number | NA |
| Catalog Number | 624519 |
| Lot Number | 4717 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 AVE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-04 |