MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-25 for ACT 5 DIFF WBC LYSE REAGENT ACT 5 DIFF LYSE 8547170 manufactured by Beckman Coulter, Inc..
[15505630]
A customer contacted beckman coulter inc. (bec) indicating that the act 5 diff wbc lyse reagent leaked in transit, prior to receiving. When the operator opened the box, the lyse bottle was contained in a plastic bag with a wire tie on it. The operator was not wearing proper personal equipment (ppe). There were no reports of exposure to mucous membranes or open wounds and no one sought medical attention. Patient results were not affected in this event.
Patient Sequence No: 1, Text Type: D, B5
[15797203]
The customer was sent a replacement. Root cause for the leak is unknown. However, there is an open ongoing failure investigation for leaks associated with the act 5 diff wbc lyse product. Per labeling, avoid eye and skin contact. In case of eye or skin contact, flush affected area with copious amounts of water for at least 15 minutes. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00993 |
| MDR Report Key | 2176384 |
| Report Source | 06 |
| Date Received | 2011-07-25 |
| Date of Report | 2011-06-20 |
| Date of Event | 2011-06-20 |
| Date Mfgr Received | 2011-06-20 |
| Device Manufacturer Date | 2011-01-24 |
| Date Added to Maude | 2012-06-15 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACT 5 DIFF WBC LYSE REAGENT |
| Generic Name | RED CELL LYSING REAGENT |
| Product Code | GGK |
| Date Received | 2011-07-25 |
| Model Number | ACT 5 DIFF LYSE |
| Catalog Number | 8547170 |
| Lot Number | 15002B |
| Device Expiration Date | 2012-01-24 |
| 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 AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-25 |