MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC MEDICHOICE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number BTD002

Device Problems Detachment Of Device Component (1104); Defective Device (2588)

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

Event Date 01/30/2018

Event Type  malfunction  

Event Description

Blood transfer devices defective.While transferring blood from syringe to blood culture bottle, plastic covering the needle in transfer device came unattracted and stuck in the blood culture bottle.This happened three times on 2 patients.Manufacturer response for blood transfer device, (brand not provided) (per site reporter): manufacturer has not responded.

• Brand Name: MEDICHOICE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 7262963
• MDR Text Key: 99816054
• Report Number: 7262963
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BTD002
• Device Catalogue Number: BTD002
• Device Lot Number: 1609DH02A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO