MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-08-09 for COULTER? PREPPLUS 2 378600 manufactured by Beckman Coulter, Inc..
[2738501]
A customer reported that a tube came off the probe on coulter prepplus 2 instrument and fluid squirted onto the customer's face. The volume of the squirted fluid is unknown. The instrument is used for preparing hiv samples, and the waste line contains isoflow sheath fluid, controls and patient samples. There was no death or injury and medical attention was not sought. It is unknown if the customer was wearing personal protective equipment at the time of the incident. Msds was not reviewed and there is no risk management plan in place at the customer's site. There has been no report that any patient results were affected. A field service engineer cleared the sample probe and remade the tubing connection. All tubing connections and probe operation passed verification test. The cause of the tube disconnection from the probe is unknown.
Patient Sequence No: 1, Text Type: D, B5
[10170386]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-02246 |
| MDR Report Key | 2689769 |
| Report Source | 01,05,06 |
| Date Received | 2012-08-09 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-07-17 |
| Date Mfgr Received | 2012-07-17 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2012-11-28 |
| 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 | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC |
| Manufacturer Street | 11800 SW 147TH AVE. |
| 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 | COULTER? PREPPLUS 2 |
| Generic Name | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2012-08-09 |
| Model Number | PREPPLUS 2 |
| Catalog Number | 378600 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-09 |