MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE BLOOD TRANSFER DEVICE

Model Number BTD001

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913); Free or Unrestricted Flow (2945)

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

Event Date 04/17/2017

Event Type  malfunction  

Event Description

Staff was experiencing problems with the new medichoice blood transfer device.According to the nurse report, the staff has been reporting that the grey rubber sheath (vacuum tube side of the device) has been hard to penetrate while placing the collection tube during a blood draw.Additionally, a technician has reported that the grey rubber sheath came off the vacutainer needle and stayed in the sample tube after it was removed during a blood draw.In a second instance, the technician was drawing labs including blood cultures with the vacutainer.The rubber piece of the vacutainer became lodged in the rubber top of the blood culture bottle, exposing the needle in the vacutainer.This resulted in free flowing blood from the vacutainer; the hcp was exposed to blood on his clothes and shoes.This item was brought in as a substitute for a different manufacturer's product which is normally used.We have had no issues with this other manufacturer's product.

Event Description

Staff was experiencing problems with the new medichoice blood transfer device.According to the nurse report, the staff has been reporting that the grey rubber sheath (vacuum tube side of the device) has been hard to penetrate while placing the collection tube during a blood draw.Additionally, a technician has reported that the grey rubber sheath came off the vacutainer needle and stayed in the sample tube after it was removed during a blood draw.In a second instance, the technician was drawing labs including blood cultures with the vacutainer.The rubber piece of the vacutainer became lodged in the rubber top of the blood culture bottle, exposing the needle in the vacutainer.This resulted in free flowing blood from the vacutainer; the hcp was exposed to blood on his clothes and shoes.This item was brought in as a substitute for a different manufacturer's product which is normally used.We have had no issues with this other manufacturer's product.Initial email response received from manufacturer's sales rep mentioned there was a design change, however no formal manufacturer response has been received at this time.

• Brand Name: MEDICHOICE BLOOD TRANSFER DEVICE
• Type of Device: BLOOD TRANSFER DEVICE
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd.; mechanicsville VA 23116
• MDR Report Key: 6551095
• MDR Text Key: 74625236
• Report Number: 6551095
• Device Sequence Number: 1
• Product Code: KSB
• 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,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/01/2019
• Device Model Number: BTD001
• Device Catalogue Number: BTD001
• Device Lot Number: 1610DH01A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2017
• 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