MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN VACUTAINER SST TUBE; BLOOD COLLECTION TUBE

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Results: investigation summary: as bd life sciences - preanalytical systems had not received any sample, photo, catalog number, and/or lot number from the customer facility for evaluation, an investigation could not be performed as no information was available for review.Investigation conclusion: as bd life sciences - preanalytical systems had not received any sample, photo, catalog number, and/or lot number from the customer facility for evaluation, an investigation could not be performed as no information was available for review.Root cause description: as bd life sciences - preanalytical systems had not received any sample, photo, catalog number, and/or lot number from the customer facility for evaluation, an investigation could not be performed as no information was available for review.

Event Description

It was reported an unknown vacutainer sst tube sometimes leak while in the phlebotomist's lab coat pockets.There was no report of injury or medical intervention.

• Brand Name: UNKNOWN VACUTAINER SST TUBE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7151061
• MDR Text Key: 96126783
• Report Number: 2243072-2017-00413
• Device Sequence Number: 0
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Phlebotomist
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other