MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 366408

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that erroneous results occurred after use with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter, "it is reported plastic composition may have factored in erroneous results.Customer reports this incident occurring prior, no specific date, no medical invention, no treatment change, no result information, no samples and no further information.Result was negative for clonazepam but when sent out it was positive.Comment type: work performed informed the patient that the tube is made of polyethylene terethphalate (pet) plastic.She stated that manual stated interference with some types of plastics, and she needed to know what the plastic the tubes are made of.She will follow up to see if this pet will interfere with her testing.".

Manufacturer Narrative

H.6 investigation: a sample or photo is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.

Event Description

It was reported that erroneous results occurred after use with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter, it is reported plastic composition may have factored in erroneous results.Customer reports this incident occurring prior, no specific date, no medical invention, no treatment change, no result information, no samples and no further information.Result was negative for clonazepam but when sent out it was positive.Comment type: work performed informed the patient that the tube is made of polyethylene terethphalate (pet) plastic.She stated that manual stated interference with some types of plastics, and she needed to know what the plastic the tubes are made of.She will follow up to see if this pet will interfere with her testing.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 9377232
• MDR Text Key: 179507281
• Report Number: 1024879-2019-02053
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 366408
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other