MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-02-26 for DXH CELL LYSE 8547170 manufactured by Beckman Coulter, Inc..
[2521026]
Customer reported to beckman coulter, inc. (bec) that they received a bottle of ac t 5 diff wbc lyse that was leaking due to a loose cap. There was no report of patient results affected. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9608047]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-00606 |
| MDR Report Key | 2468689 |
| Report Source | 01,07 |
| Date Received | 2012-02-26 |
| Date of Report | 2012-02-01 |
| Date of Event | 2012-02-01 |
| Date Mfgr Received | 2012-02-01 |
| Device Manufacturer Date | 2011-10-17 |
| Date Added to Maude | 2012-08-23 |
| 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. DUNG NGUYEN |
| 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 | DXH CELL LYSE |
| Generic Name | PRODUCTS, RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2012-02-26 |
| Catalog Number | 8547170 |
| Lot Number | 16202B |
| Device Expiration Date | 2012-10-17 |
| Device Availability | N |
| 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 | 2012-02-26 |