MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-08 for COULTER 5C CELL CONTROL 7547114 manufactured by Beckman Coulter, Inc..
[15540793]
Customer reported potential biohazard when the vials in the coulter 5c cell control kit were leaking between the rubber stopper and the cap. Leakage occurred after 3-4 pierces. Operator was wearing personal protective equipment and there was no exposure to mucous membranes or open lesions. No reports of death or serious injury, and no affect to operator safety as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[15940372]
Two levels within the kit exhibited the leakage. The open vial claim is 13 times within 13 days. Product labeling states: "this specimen/reagent should be handled at biosafety level 2, as recommended for any potentially infectious human serum or blood specimen in the centers for disease control/national institutes of health manual "biosafety in microbiological and biomedical laboratories," 1988. " customer return product was not available for eval. Complaint review was conducted. There was no other reported event for 5c cell control vials leaking between rubber stopper and cap within the last 12 months. Root cause is unk. This reportable event was identified during a retrospective review conducted between (b)(4), 2008 and (b)(4), 2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00813 |
| MDR Report Key | 2183643 |
| Report Source | 05,06 |
| Date Received | 2011-07-08 |
| Date of Report | 2008-04-15 |
| Date of Event | 2008-04-15 |
| Date Mfgr Received | 2008-04-15 |
| Device Manufacturer Date | 2008-02-29 |
| Date Added to Maude | 2012-05-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 5C CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-07-08 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 1001093K |
| ID Number | NA |
| Device Expiration Date | 2008-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2011-07-08 |