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 4C PLUS COULTER CELL CONTROL 7547025 manufactured by Beckman Coulter, Inc..
[2260842]
A customer reported to beckman coulter inc. (bec) that the 4c plus coulter cell control tube was leaking. Per the customer, the control had been used twice in previous occasions and was half full when the incident occurred. The control was stored in a cup in the refrigerator. The customer picked up the glass tube to wipe the leak, the glass vial broke and the contents spilled. The customer did not cut herself with the broken glass nor was exposed to the contents of the control tube. The user was wearing personal protective equipment (ppe) consisting of lab coat and gloves at the time of the event. No injuries occurred and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds. There was no change to patient treatment attributed or associated to this complaint.
Patient Sequence No: 1, Text Type: D, B5
[9415150]
The msds was not reviewed, however it is readily available. The lab's exposure control or risk management plans are in place. Per labeling, 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 it is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer. The control tube was not replaced since the damaged vial had been previously used and was already half at the time of the event. The root cause of the leak is unknown. Bec internal number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01579 |
| MDR Report Key | 2271115 |
| Report Source | 05,06 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-09-01 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2011-09-01 |
| Device Manufacturer Date | 2011-08-09 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 CULTER INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| 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 | 4C PLUS COULTER CELL CONTROL |
| Generic Name | MIXTURE, HEMATOLOGY QUALITY CONTROL |
| Product Code | JPK |
| Date Received | 2011-09-30 |
| Model Number | NA |
| Catalog Number | 7547025 |
| Lot Number | 1109276K |
| ID Number | NA |
| Device Expiration Date | 2011-10-14 |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-30 |