MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-09-16 for S-CAL? CALIBRATOR 624519 manufactured by Beckman Coulter Inc..
[2176871]
The customer reported that on (b)(6) 2011 they observed red smears on the outside of the s-cal calibrator packaging that was thought to be possibly blood or red ink. The smears were discovered during receiving inspection. No patient results were affected by this event. Upon observance of the smears the suspect products were kept in a plastic bag and quarantined as non-conforming goods. The personnel involved in this event were wearing personal protective equipment, which included laboratory coats, gloves and face masks, at the time of occurrence. There was no biohazardous exposure to personnel uncovered wounds or mucous membranes and no injuries were reported. No personnel sought any medical attention in association with this event. No death, injury or modification to patient treatment was associated with this event. There was an exposure plan in place at the facility and the material safety data sheet was reviewed.
Patient Sequence No: 1, Text Type: D, B5
[9290808]
Beckman coulter inc. Evaluation of pictures of the event show the presence of multiple smudges on the outer package of the s-cal calibrator packaging. The source of the smudges is unknown. It is unknown as to what the red smudges are. A definitive root cause for this event is unknown at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01458 |
| MDR Report Key | 2250512 |
| Report Source | 01,05,06 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-08-03 |
| Date of Event | 2011-08-03 |
| Date Mfgr Received | 2011-08-03 |
| Device Manufacturer Date | 2011-07-14 |
| 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 |
| 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 | 2011-09-16 |
| Model Number | NA |
| Catalog Number | 624519 |
| Lot Number | 1158175F |
| ID Number | NA |
| Device Expiration Date | 2011-08-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-09-16 |