MAUDE Adverse Event Report: SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK ; TUBES, VIALS, SYSTEMS, BLOOD COLLECTION

Model Number MBT01

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 08/05/2019

Event Type  malfunction  

Event Description

The facility had four reported events within two week time span as follows: while drawing blood cultures the blood draw device (summit medical blood collection assembly with male luer lock product no.Mbt01) malfunctioned.The grey rubber sheath that covers the needle became dislodged in the vacutainer and occluded the flow of blood.This was unable to be resolved and the procedure needed to be repeated with a second venous puncture to obtain the necessary lab work.On the second attempt the same malfunction occurred, however the grey rubber sheath or the second attempt ruptured completely and blood flow was able to be recovered and the sample was obtained.This caused delay of care, and had the potential to cause contaminated blood cultures.Product was pulled from pt care units and replaced.Purchased through (b)(6).Fda safety report id# (b)(4).

• Brand Name: BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
• Type of Device: TUBES, VIALS, SYSTEMS, BLOOD COLLECTION
• Manufacturer (Section D): SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES; franklin MA 02038
• MDR Report Key: 8965058
• MDR Text Key: 156811624
• Report Number: MW5089561
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/03/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: MBT01
• Device Lot Number: 20190110
• 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