MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-14 for 4C PLUS COULTER? CELL CONTROL 7547114 manufactured by Beckman Coulter Inc..
[18495707]
A customer contacted beckman coulter inc. (bec) reporting that a coulter 4c plus cell control tube was leaking blood. Per customer, the cap of the leaking tube appeared to be damaged. The user was wearing personal protective equipment (ppe) consisting of gloves at the time of the incident. No injury or exposure was reported and medical attention was not sought.
Patient Sequence No: 1, Text Type: D, B5
[18741917]
The root cause of the leak was that the cap of the control tube was damaged. The customer was sent a replacement set of controls. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01716 |
| MDR Report Key | 2295400 |
| Report Source | 05,06 |
| Date Received | 2011-10-14 |
| Date of Report | 2011-09-13 |
| Date of Event | 2011-09-13 |
| Date Mfgr Received | 2011-09-13 |
| Device Manufacturer Date | 2011-08-09 |
| Date Added to Maude | 2012-07-06 |
| 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 |
| Health Professional | 0 |
| 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 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 | HEMATOLOGY QUALITY CONTROL MIXTURE |
| Product Code | JPK |
| Date Received | 2011-10-14 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 067200 |
| ID Number | NI |
| Device Expiration Date | 2011-10-14 |
| 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 AVENUE, MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-14 |