MAUDE Adverse Event Report: BD BD VACUTAINER TUBE PST GEL AND LIHE 83 UNITS; TUBES, VIALS, SYSTEMS, SERUM SEPARATOR

Catalog Number 367962

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 07/05/2018

Event Type  malfunction  

Event Description

We started using the bd lithium heparin tubes (367962, lot # 8061753 on (b)(6) 2018 and continued until (b)(6) 2018) when we identified this problem.The bd lithium heparin separator tubes have a positive bias for ast of approx 50%.Sodium's and calcium also could have a problem of slight positive bias.While only one patient is listed above, we will be re-drawing blood and repeating tests for approx 205 patients.An unk number of patients received additional testing (lab and imaging) as a result of their abnormal results.Several physicians questioned results of patient that had routine/previous testing which initiated our investigation.After determining the vacutainer tube could be the cause, we removed this product which all had the same lot number.

• Brand Name: BD VACUTAINER TUBE PST GEL AND LIHE 83 UNITS
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATOR
• Manufacturer (Section D): BD; franklin lakes NJ 07417
• MDR Report Key: 7717888
• MDR Text Key: 115090457
• Report Number: MW5078579
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 367962
• Device Lot Number: 8061753
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR