MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-07 for COULTER 4C CELL CONTROL, TRI-PACK 7547187 manufactured by Beckman Coulter, Inc..
[16121754]
The customer had contacted beckman coulter, inc. (bec) to report that a vial of their coulter 4c cell control, tri-pack leaked due to a crack in the cap while mixing the vial before assaying. The customer was wearing personal protective equipment at the time of the event. Approximately 1 ml of coulter 4c cell control leaked onto the customer's pant leg, shoes, and the floor. There was no exposure to mucous membranes or open lesions. There was no report of death or serious injury associated with this event. Medical attention was not sought. The laboratory has a risk management plan in place. The material safety data sheet (msds) was available, but was not reviewed by the customer at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[16337327]
Product labeling states: "beckman coulter, inc. Urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer. " the control vial was disposed of the customer into a biohazard sharps container. The root cause was not determined. Product labeling contains sufficient warnings/precautions addressing potential biohazard events. This reportable event was identified during a retrospective review conducted between january 01, 2008 and october 23, 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01649 |
| MDR Report Key | 2320056 |
| Report Source | 05,06 |
| Date Received | 2011-10-07 |
| Date of Report | 2009-07-30 |
| Date of Event | 2009-07-01 |
| Date Mfgr Received | 2009-07-30 |
| Date Added to Maude | 2012-06-29 |
| 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. 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 4C CELL CONTROL, TRI-PACK |
| Product Code | JPK |
| Date Received | 2011-10-07 |
| Model Number | NA |
| Catalog Number | 7547187 |
| Lot Number | 1685147K |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-10-07 |