MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-05 for COULTER LYSE S III DIFF LYTIC REAGENT 8546796 manufactured by Beckman Coulter, Inc..
[21649742]
Customer reported a potential chemical exposure when using the coulter lyse s iii diff lytic reagent. The operator was securing the pickup tubing onto the coulter lyse s iii diff lytic reagent container when approx 5 ml of reagent leaked out from the container cap. The leak occurred when pressure was applied to the container. The operator was wearing personal protective equipment (ppe). There was no exposure to mucous membranes, open lesions, skin or eyes. Medical treatment was not required. 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
[21747919]
Product was replaced at the time of event. Product was not returned for eval. Based upon available info root cause is unk. A review for similar events was conducted. From 2005-2010, there have been no similar reports of leaking from the container with this reagent. 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 | 1061932-2011-01063 |
| MDR Report Key | 2210136 |
| Report Source | 05,06 |
| Date Received | 2011-08-05 |
| Date of Report | 2010-03-01 |
| Date of Event | 2010-02-22 |
| Date Mfgr Received | 2010-03-01 |
| Date Added to Maude | 2012-06-20 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 LYSE S III DIFF LYTIC REAGENT |
| Product Code | GGK |
| Date Received | 2011-08-05 |
| Model Number | NA |
| Catalog Number | 8546796 |
| Lot Number | 101665F |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-08-05 |