MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2011-09-23 for TRUCOLOR WRIGHT STAIN 7547177 manufactured by Beckman Coulter, Inc..
[2261866]
A beckman coulter, inc. (bci) employee reported three cases of trucolor wright stain solution leaking from their packages. The events occurred in two separate dates while the employee was packing the cases and involved two different lot numbers. The potential for chemical exposure with the reported incident was present. At one of the events the bci employee reported when lifting the case in the shipping area its content leaked from the box and fell on the clothing. The employee used the emergency shower and was sent home to change clothing. The operator was not wearing personal protection equipment. There was no report of exposure to mucous membranes or open skin lesions. The material safety data sheet (msds) was reviewed and the lab's exposure control or risk mgmt plans are in place. No injuries occurred and medical attention was not sought as a result of this event. No reports of death or serious injury, and no affect to operator safety as a result of this event. This event represents event 2 of 2 events reported by this customer and product quantity of (2).
Patient Sequence No: 1, Text Type: D, B5
[9309672]
Per labeling, 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 it is not limited to, protective eyewear, gloves, and suitable lab attire when operating or maintaining this or any other automated lab analyzer. Found damaged container/leak from original equipment mfr (oem) vendor during pick and pack process. Based on available info, the root cause can be attributed to product packing was damaged on arrival, causing the reagent to leak. This reportable event was identified during a retrospective review conducted between (b)(6) 2008 and (b)(6) 2010 of complaints for additional reportable events. This mdr represents 1 of 2 reported by this customer. This mdr is related to the following mdr that have been reported: mdr 1061932-2011-01500.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01501 |
| MDR Report Key | 2276834 |
| Report Source | 06,07,08 |
| Date Received | 2011-09-23 |
| Date of Report | 2009-03-12 |
| Date of Event | 2009-03-10 |
| Date Mfgr Received | 2009-03-12 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2012-06-27 |
| 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 | TRUCOLOR WRIGHT STAIN |
| Product Code | GKL |
| Date Received | 2011-09-23 |
| Model Number | NA |
| Catalog Number | 7547177 |
| Lot Number | 9030 |
| ID Number | NA |
| Device Expiration Date | 2010-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-09-23 |