MAUDE Adverse Event Report: BIO-RAD LABORATORIES LIQUID UNASSAYED MULTIQUAL; QUALITY CONTROL MATERIAL

Catalog Number 699

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2014

Event Type  No Answer Provided  

Event Description

Employee was reaching into the freezer to grab a jar of product.One of the jars had apparently shattered during shipment; however no staff were aware of this and the broken jar/glass had not been removed from the package.The employee did not visualize the package prior to reaching in, which resulted in a laceration to his right index finger when he contacted the broken glass.The employee washed the are with soap and water and sought medical attention for possible blood-bourne pathogen exposure counseling at a local clinic.

Manufacturer Narrative

The labeling and certificate of analysis for liquid unassayed multiqual indicates that each human donor unit used to manufacture the product was tested by fda accepted methods and found (b)(6).In addition, the labeling instructs the users to treat all human source material as potentially infections and should be handled with the same precautions used with patient specimens.

• Brand Name: LIQUID UNASSAYED MULTIQUAL
• Type of Device: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): BIO-RAD LABORATORIES; 9500 jeronimo rd.; irvine CA 92618
• Manufacturer Contact: elizabeth platt ; 9500 jeronimo rd.; irvine, CA 92618 ; 9495981285
• MDR Report Key: 4009917
• MDR Text Key: 4956697
• Report Number: 2016706-2014-00001
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 699
• Device Lot Number: 46463
• Other Device ID Number: +M235Q6992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other