MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2011-11-08 for DXH 800 CELL LYSE 628019 manufactured by Beckman Coulter, Inc..
[2337607]
It was reported that a bottle of dxh cell lyse was found to be leaking upon arrival to the beckman coulter inc. , (bec) warehouse in (b)(4). The package was damped on arrival and while attempting to remove the container the package ripped causing a fluid spill. The warehouse personnel stated that they were wearing appropriate personal protective equipment (ppe) consisting of gloves, goggles and laboratory coat when the event occurred. No injuries occurred and no one sought medical attention. There was no report of exposure to mucous membranes or open wounds. The material safety data sheet (msds) was reviewed and there is an exposure/risk management plan in place at the facility. There was no report of death or injury in connection to this event.
Patient Sequence No: 1, Text Type: D, B5
[9389443]
Per msds labeling: safety glasses or chemical goggles should be worn to prevent eye contact. Refer (b)(4) or appropriate government standards and impervious gloves, such as nitrile or equivalent, should be worn to prevent skin contact. Refer (b)(4) or appropriate government standards. No additional information is available. The root cause for the leak is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02088 |
| MDR Report Key | 2328395 |
| Report Source | 01,07,08 |
| Date Received | 2011-11-08 |
| Date of Report | 2011-10-11 |
| Date of Event | 2011-10-11 |
| Date Mfgr Received | 2011-10-11 |
| Device Manufacturer Date | 2011-10-04 |
| Date Added to Maude | 2012-07-13 |
| 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 NGYUEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN CULTER 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DXH 800 CELL LYSE |
| Generic Name | PRODUCTS, RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2011-11-08 |
| Model Number | NA |
| Catalog Number | 628019 |
| Lot Number | 1707001 |
| ID Number | NA |
| Device Expiration Date | 2013-04-04 |
| 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 | 2011-11-08 |