MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-01 for COULTER 5C CELL CONTROL 7547001 manufactured by Beckman Coulter, Inc..
[2138149]
Customer reported a potential biohazard event when using the coulter 5c cell control. The abnormal ii vial in the kit was exhibiting a slow drip when inverted. This drip was from the cap and occurred after 13 pierces. The operator was wearing personal protective equipment at the time of the incident. 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. This event represents event 1 of 2 events reported by this customer for the first of two lots.
Patient Sequence No: 1, Text Type: D, B5
[9140056]
The abnormal ii vial had been pierced over thirteen (13) times. The open vial claim as stated in the table of expected results is thirteen times (13) times within thirteen (13) days. The other two control levels within the kit did not exhibit this issue. 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 (b)(4) "biosafety in microbiological and biomedical laboratories," 1988. " eval of customer return product by a package engineer concluded that the stopper exhibited an unusual hole at the stopper pierce site and the stopper hole does permit product to escape. On (b)(6) 2008, the field service engineer evaluated the coulter maxm w/autoloader (including needle alignment). Analyzer met published performance specifications and did not require any adjustment. Root cause was determined to be user error. This reportable event was identified during a retrospective review conducted between (b)(6) 2008 and (b)(6) 2010 of complaints for add'l reportable events. This mdr represents event 1 of 2 reported by this customer. This mdr is related to the following mdrs that have been reported: mdr 1061932-2011-00761.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00748 |
| MDR Report Key | 2171272 |
| Report Source | 05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2008-03-06 |
| Date of Event | 2008-03-06 |
| Date Mfgr Received | 2008-03-06 |
| Device Manufacturer Date | 2008-01-08 |
| 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 | 2011-07-01 |
| Model Number | NA |
| Catalog Number | 7547001 |
| Lot Number | 1028046K |
| ID Number | NA |
| Device Expiration Date | 2008-03-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-07-01 |