MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-04-15 for TOTAL AND DIRECT BILIRUBIN CALIBRATOR 465915 manufactured by Beckman Coulter, Inc..
[2602391]
On (b)(6) 2012, beckman coulter warehouse in (b)(6) reported that they received one kit of total/direct bilirubin calibrator that leaked due to breakage upon receipt. It was determined that the cause of the leak was a broken ampule. 3 out of 10 ampules were broken with a total volume of 3 ml. No injury was reported and the material handler was wearing safety glasses and gloves. It was decided that an mdr should be filed because the calibrator contains material of human and animal origins that may be potentially infectious, and upon recur, serious injury could occur.
Patient Sequence No: 1, Text Type: D, B5
[9802734]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050010-2012-00015 |
| MDR Report Key | 2535782 |
| Report Source | 01,07 |
| Date Received | 2012-04-15 |
| Date of Report | 2012-03-27 |
| Date of Event | 2012-03-27 |
| Date Mfgr Received | 2012-03-27 |
| Device Manufacturer Date | 2011-06-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 2470 FARADAY AVE. |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTAL AND DIRECT BILIRUBIN CALIBRATOR |
| Generic Name | CALIBRATOR, PRIMARY |
| Product Code | JIS |
| Date Received | 2012-04-15 |
| Catalog Number | 465915 |
| Lot Number | M103319 |
| Device Expiration Date | 2012-10-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-15 |