MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-01 for DIFF AC-T PAK REAGENT 15L 8547134 manufactured by Beckman Coulter, Inc..
[2073492]
An operator reported diluent was splashed into her eyes as she was opening the seal on reagent #1 in the diff ac-t pak reagent 15l. The operator was wearing safety glasses, gloves and lab coat. However, her safety glasses were insufficient to prevent exposure. The operator flushed her eyes with water for 15 mins and sought medical attention. The operator stated that she is not injured. It is unk if intervention was required when the operator sought medical attention.
Patient Sequence No: 1, Text Type: D, B5
[9202452]
Review of product labeling on the material safety data sheet (msds) (b)(4), provides the following instruction: "if product enters eyes, wash eyes gently under running water for 15 mins or longer, making sure eyelids are held open. If pain or irritation occur, obtain medical attention. " the msds also contains the following for eye protection: "safety glasses or chemical goggles should be worn to prevent eye contact. " product labeling analysis determined labeling is sufficient. Root cause for this event was not determined. User error contributed to the event as eye protection was insufficient to prevent splashing from entering eye area. 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 | 1061932-2011-00649 |
| MDR Report Key | 2156005 |
| Report Source | 05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2010-01-29 |
| Date of Event | 2010-01-29 |
| Date Mfgr Received | 2010-01-29 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2011-07-13 |
| 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 | DIFF AC-T PAK REAGENT 15L |
| Product Code | GGK |
| Date Received | 2011-07-01 |
| Model Number | NA |
| Catalog Number | 8547134 |
| Lot Number | 114145K |
| ID Number | NA |
| Device Expiration Date | 2010-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2011-07-01 |