MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-30 for COULTER 4C PLUS CELL CONTROL TRI-PACK 7547114 manufactured by Beckman Coulter, Inc..
[2284278]
The customer has contacted beckman coulter, inc. (bec) to report that a high control vial from a shipment of coulter 4c plus cell control tri-pack was leaking upon receipt. The customer reported that the contents of the high control vial were hemolyzed upon receipt. The customer was wearing personal protective equipment at the time of the event. There was no exposure to mucous membranes or open lesions. There was no leak of the high control vial on the counter or the floor. There was no report of death or serious injury associated with this event. Medical attention was not sought. The customer was unsure if the laboratory has a spill control procedure in place. It is unknown if the laboratory has a risk management plan in place. It is unknown if the customer reviewed the material safety data sheet (msds) at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[9309344]
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. " service was not dispatched for this event. Product was not returned for evaluation. 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 (b)(6) 2008 and (b)(6) 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01585 |
| MDR Report Key | 2281692 |
| Report Source | 05,06 |
| Date Received | 2011-09-30 |
| Date of Report | 2009-06-01 |
| Date of Event | 2009-06-01 |
| Date Mfgr Received | 2009-06-01 |
| Date Added to Maude | 2012-06-28 |
| 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 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 PLUS CELL CONTROL TRI-PACK |
| Product Code | JPK |
| Date Received | 2011-09-30 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 100237K |
| 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 | 2011-09-30 |