MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-22 for COULTER ACT RINSE SHUTDOWN DILUENT 8547113 manufactured by Beckman Coulter, Inc..
[2044779]
Customer reported a potential chemical hazard when the coulter act rinse shutdown diluent was leaking. The package had a broken seal and was leaking upon receipt. The operator was not wearing personal protective equipment at the time of the incident. There was no spill on the floor or counter and no reagent material spilled on the operator. There was no exposure to mucous membranes, skin, eyes or inhalation. 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
[9207429]
A review for similar events was conducted. There has been only one additional report of reagent leaking upon receipt during 2004 to 2009. Root cause is unknown. This reportable event was identified during a retrospective review conducted between (b)(4) 2008 and (b)(4) 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00918 |
| MDR Report Key | 2185199 |
| Report Source | 05,06 |
| Date Received | 2011-07-22 |
| Date of Report | 2009-12-23 |
| Date of Event | 2009-12-22 |
| Date Mfgr Received | 2009-12-23 |
| Date Added to Maude | 2012-05-31 |
| 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 ACT RINSE SHUTDOWN DILUENT |
| Product Code | JCB |
| Date Received | 2011-07-22 |
| Model Number | NA |
| Catalog Number | 8547113 |
| Lot Number | 114153K |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-07-22 |