MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-19 for 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE ACT 5 CALIBRATOR 7547175 manufactured by Beckman Coulter, Inc..
[16044418]
Customer called on (b)(6) 2011 reporting that upon opening a shipment of the act 5 calibrator, one of the vial was found to have leaked (approximately 2 ml) inside the product box. Customer stated that the package was opened to find if the vial was broken but found that the vial was intact. Customer mentioned that the reason for the leak was that the cap was not screwed on tightly on one of the 2 vials. The package was disposed of in customer's biohazard container and hotline had arranged for a replacement. Customer was wearing personal protective equipment consisting of a lab coat and gloves at the time of the event and no one was exposed to the leak. Customer also reported that no injury had resulted from the event. Root cause for the leak is potentially attributed to the cap not being screwed on tightly onto the vial.
Patient Sequence No: 1, Text Type: D, B5
[16194848]
Method: evaluation was done by the customer. Customer stated that the season for the leak was that the cap was not screwed on tightly on one of the two vials. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-00181 |
| MDR Report Key | 2421940 |
| Report Source | 05,06 |
| Date Received | 2012-01-19 |
| Date of Report | 2011-12-29 |
| Date of Event | 2011-12-29 |
| Date Mfgr Received | 2011-12-29 |
| Device Manufacturer Date | 2011-11-15 |
| Date Added to Maude | 2012-08-07 |
| 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 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 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE |
| Generic Name | CALIBRATOR FOR CELL INDICES |
| Product Code | KRX |
| Date Received | 2012-01-19 |
| Model Number | ACT 5 CALIBRATOR |
| Catalog Number | 7547175 |
| Lot Number | CX436 |
| Device Expiration Date | 2012-02-05 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-01-19 |