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 COULTER ACT TAINER REAGENT KIT 8547111A manufactured by Beckman Coulter, Inc..
[2221492]
The customer had contacted beckman coulter, inc (bec) to report that a coulter act tainer reagent kit package was leaking upon receipt. The customer reported that the leaking was contained within the package. There was no spill on the counter, the floor, or on the customer. The customer was not wearing personal protective equipment at the time of the event. There was no exposure to mucous membranes or open lesions. There was no report of death or serious injury associated with this event. There was no report of medical attention being sought. It is unk if the lab has a risk mgmt plan in place. It is unk if the material safety data sheet (msds) was reviewed. There was no impact to pt sample results or pt treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9377403]
Product labeling states: "beckman coulter, inc urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable lab attire when operating or maintaining this or any other automated lab analyzer. " svc was not dispatched for this event. There was no reported damage to the exterior of the shipping container. The product was not returned for eval. The root cause was not determined. Product labeling contains sufficient warnings/precautions addressing potential biohazard events. 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 | 1061932-2011-01763 |
| MDR Report Key | 2326235 |
| Report Source | 05,06 |
| Date Received | 2011-10-14 |
| Date of Report | 2009-09-28 |
| Date of Event | 2009-09-28 |
| Date Mfgr Received | 2009-09-28 |
| 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 | 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 TAINER REAGENT KIT |
| Product Code | GGK |
| Date Received | 2011-10-14 |
| Model Number | NA |
| Catalog Number | 8547111A |
| Lot Number | 115168K |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-10-14 |