MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-09 for A.T 5DIFF WBC LUSE 8547170 manufactured by Beckman Coulter, Inc..
[2162205]
The customer reported receiving a shipment containing (8) bottles of a. T 5 diff wbc lyse reagent that were leaking and having the potential for a chemical exposure. Lot numbers were not available. The shipping container was not damaged. The user was wearing personal protective equipment (ppe) consisting of lab coat and gloves at the time of the incident. No injuries occurred and medical attention was not sought as a result of this event. There was no report of exposure to mucous membranes, skin or open wounds. The material safety data sheet (msds) was not reviewed; however, it is readily available. There was no death, injury or change to pt treatment attributed or associated to this complaint.
Patient Sequence No: 1, Text Type: D, B5
[9326341]
The customer discarded the leaking reagent bottles; as a result, product is not available for eval. The root cause is unk. Replacement product was provided. This reportable event was identified during a retrospective review conducted between (b)(4) 2008 through (b)(4) 2010 of complaints for add? L reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01401 |
| MDR Report Key | 2251232 |
| Report Source | 05,06 |
| Date Received | 2011-09-09 |
| Date of Report | 2009-03-17 |
| Date of Event | 2009-03-16 |
| Date Mfgr Received | 2009-03-17 |
| Date Added to Maude | 2012-06-25 |
| 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 BLVDL |
| 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 | A.T 5DIFF WBC LUSE |
| Product Code | GGK |
| Date Received | 2011-09-09 |
| Model Number | NA |
| Catalog Number | 8547170 |
| Lot Number | UNK |
| 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 | 2011-09-09 |