MAUDE Adverse Event Report: BIO-RAD, DIAGNOSTICS GRP. LIQUICHEK SEDIMENTATION RATE CONTROL; QUALITY CONTROL MATERIAL

Catalog Number 514

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2014

Event Type  Injury  

Event Description

In (b)(6), a laboratory technologist cut her index finer on a becton-dickinson sedimentation tube containing liquichek sedimentation rate control while applying pressure to a stopper on the tube.The laboratory technologist sought medical treatment and was given (b)(6).

Manufacturer Narrative

The labeling and certificate of analysis of liquichek sedimentation rate control 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 user to treat all human source material as potentially infection and should be handled with the same precautions used with patient specimens.

• Brand Name: LIQUICHEK SEDIMENTATION RATE CONTROL
• Type of Device: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): BIO-RAD, DIAGNOSTICS GRP.; 9500 jeronimo rd.; irvine CA 92618 201
• Manufacturer Contact: elizabeth platt ; 9500 jeronimo rd.; irvine, CA 92618-2017 ; 9495981258
• MDR Report Key: 4203434
• MDR Text Key: 4983659
• Report Number: 2016706-2014-00002
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2014
• Device Catalogue Number: 514
• Device Lot Number: 15841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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