MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE BLOOD TRANSFER DEVICE; SET, TRANSFER (BLOOD/PLASMA)

Model Number BTD001

Device Problem Break (1069)

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

Event Date 02/05/2019

Event Type  malfunction  

Event Description

Malfunction of the medichoice blood transfer device with male luer lock lot# 1809dh01a.I have the used broken piece in my office for review if needed.Faulty transfer device used on patient.A piece of the transfer device broke off inside the extension set allowing blood to flow freely and all over the patient before i could clamp off the set and replace with a new extension set.I labeled the extension set with the broken piece from the transfer device and left it at the charge desk with wrapper from the transfer device.This is the second instance that this has happened in the last 2 weeks.Location: emergency department.

• Brand Name: MEDICHOICE BLOOD TRANSFER DEVICE
• Type of Device: SET, TRANSFER (BLOOD/PLASMA)
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 8342870
• MDR Text Key: 136261278
• Report Number: 8342870
• Device Sequence Number: 1
• Product Code: KSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2019

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: BTD001
• Device Catalogue Number: BTD001
• Device Lot Number: 1809DH01A
• 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: 02/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1