MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-17 for 4C PLUS COULTER CELL CONTROL 7547114 manufactured by Beckman Coulter, Inc..
[17412045]
Customer reported a potential biohazard when the normal control material in the 4c plus coulter cell control leaked onto her hand during mixing. The customer was not wearing gloves. She stated that she had no cuts or open wounds. The customer washed her hands with soap and water. The customer did not seek medical attention. 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
[17654028]
Copies of the instructions for use (ifu, pn (b)(4)) and materials safety data sheet (msds, pn (b)(4)) were provided to the customer. Both documents recommend that the product be treated as potentially infectious material and that appropriate personal protective equipment (ppe) be worn when handling the product. The customer stated that the vial was pierced less than the allowable 31 times in 35 days (assay sheet, pn (b)(4)) and of the three vials in use, only the normal control vial leaked. The customer also indicated that the instrument probe was not the cause of the leaker as the other controls did not leak. Instrument service was not requested. The product vial was requested to be returned for eval, but was not received. Root cause for the leakage was not determined. 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 | 1061932-2011-00609 |
| MDR Report Key | 2161057 |
| Report Source | 05,06 |
| Date Received | 2011-06-17 |
| Date of Report | 2008-12-01 |
| Date of Event | 2008-12-01 |
| Date Mfgr Received | 2008-12-01 |
| Date Added to Maude | 2012-04-24 |
| 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 | 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 AVENUE |
| 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 COULTER CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-06-17 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 070000 |
| ID Number | NA |
| Device Expiration Date | 2009-01-10 |
| 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 AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-17 |