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 2011-11-15 for COULTER FLOW COUNT 7547053 manufactured by Beckman Coulter, Inc..
[2357916]
The customer reported that when he was removing the foil from the top of a vial of flow-count with scissors, he cut the index finger of his left hand. At the time of the injury he was wearing a lab coat and goggles but he was not wearing gloves as instructed in both the msds (material safety data sheet) and product's instructions for use. The operator sought first aid for the cut on his finger. The wound was cleaned with alcohol with a band-aid applied. He returned to work the same day. Coulter flow count is used in conjunction with the coulter fc 500 flow cytometer.
Patient Sequence No: 1, Text Type: D, B5
[9463284]
This reportable event was identified during a retrospective review conducted for the period between (b)(4), 2008 and (b)(4), 2010 of complaints for additional reportable events. Per the flow count package insert sheet (pn (b)(4)) statement of warnings: this reagent contains 1 percent formaldehyde. Avoid contact with skin and eyes as formaldehyde may cause irreversible effects to these tissues. Do not breathe vapors. Wear appropriate safety equipment such as gloves and eye protection. All the aluminum from the heat seal must be removed from the top of the bottle. Residual aluminum reacts with the formaldehyde and may cause a change in the appearance of the flow-count fluorospheres. Field service was not dispatched for this event. Root cause may be attributed to improper laboratory practices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02131 |
| MDR Report Key | 2339997 |
| Report Source | 01,05,06 |
| Date Received | 2011-11-15 |
| Date of Report | 2010-08-27 |
| Date of Event | 2010-08-27 |
| Date Mfgr Received | 2010-08-27 |
| Date Added to Maude | 2012-07-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| 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 AVE. |
| 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 | COULTER FLOW COUNT |
| Product Code | JPK |
| Date Received | 2011-11-15 |
| Model Number | NA |
| Catalog Number | 7547053 |
| Lot Number | 7548077F |
| ID Number | NA |
| 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 AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |