MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-18 for 4C PLUS CELL CONTROL 7547114 manufactured by Beckman Coulter, Inc..
[2357057]
The customer reported that she received a leaking beckman coulter 4c plus normal level control vial as part of a delivery to the lab. The customer stated that while visually examining the control vial, it appeared to be cracked and the cap of the control vial was not placed on the vial correctly hence resulting in the leak. The customer was wearing appropriate personal protective equipment (ppe) consisting of gloves and lab coat when the incident occurred. No injuries occurred and no-one sought medical attention. There was no report of exposure to mucous membranes or open wounds. The technician did not review the msds for the control, however, she confirmed that there is an exposure/risk management plan in place at the facility. Based on the information provided, the cause of the leaking vial was due to the crack on the cap and the cap of the control vial not being capped correctly hence resulting in the leak. A courtesy replacement was sent to the customer. Per msds labeling: this product should be handled as though capable of transmitting infectious disease. Universal precautions should be followed when using this product.
Patient Sequence No: 1, Text Type: D, B5
[9466914]
Device was disposed before notification to beckman coulter. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-02230 |
| MDR Report Key | 2341517 |
| Report Source | 05,06 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-10-19 |
| Date of Event | 2011-10-19 |
| Date Mfgr Received | 2011-10-19 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 2011-12-06 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7149614945 |
| 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 | 4C PLUS CELL CONTROL |
| Generic Name | COUNTER, DIFFERENTIAL CELL |
| Product Code | JPK |
| Date Received | 2011-11-18 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 1000427K |
| ID Number | NA |
| Device Expiration Date | 2011-12-26 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2011-11-18 |