MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-21 for DXH CELL LYSE 628019 manufactured by Beckman Coulter, Inc..
[2489663]
Upon further review, beckman coulter, inc. (bec) has determined that the malfunctioned device would not likely cause death or serious injury upon recur. Bec has determined that the incident reported by the customer was not an mdr reportable event.
Patient Sequence No: 1, Text Type: D, B5
[9718657]
.
Patient Sequence No: 1, Text Type: N, H10
[17973370]
Customer reported to beckman coulter, inc. (bec) that she received a box of dxh cell lyse 5l that was leaking. Customer reported that the box was wet and other boxes in the shipment were also wet. Customer reported that the cap on the dxh cell lyse 5l bottle was not attached securely to the bottle. Customer reported that she had a small cut on her hand which was covered by a band aid. Customer reported that she did not get the fluid on her wound. 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
[18022256]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-00562 |
| MDR Report Key | 2463132 |
| Report Source | 05,06 |
| Date Received | 2012-02-21 |
| Date of Report | 2012-01-27 |
| Date of Event | 2012-01-27 |
| Date Mfgr Received | 2012-02-23 |
| Device Manufacturer Date | 2011-10-06 |
| Date Added to Maude | 2012-08-21 |
| 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 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 | 2012-02-21 |
| Catalog Number | 628019 |
| Lot Number | 1710002 |
| Device Expiration Date | 2013-04-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-02-21 |