MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

Catalog Number 6902315

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

Cts followed up with the customer and was told, after flushing the eye, the tech went back to work without any issues.No additional medical care was provided.The tech had a tetanus shot previously, so none was provided.The site also did a baseline blood work for reference.

Event Description

The customer reporting during testing, the tech claimed red cells from the 0.8% selectogen lot # vs915 splashed into their "right eye".(b)(4).

• Brand Name: ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN
• Type of Device: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: marta carnielli ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 5608493
• MDR Text Key: 43658396
• Report Number: 2250051-2016-00024
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2016
• Device Catalogue Number: 6902315
• Device Lot Number: VS915
• Other Device ID Number: 10758750007653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1