MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE BLOOD TRANSFER DEVICE FOR USE WITH FEMALE LUER SYRINGE; SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL

Lot Number	2206DH02A
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	11/09/2023
Type of Reportable Event	Other
Event or Problem Description
Had 3 known instances where the black needle piece in the blood transfer device became detached from the rest of the blood transfer device.One was sucked into a blood culture bottle.The other two were able to be removed from the bottles.However, these put patients and personnel at risk to infectious material, blood borne pathogens and unnecessary treatment.One of the phlebotomists was sprayed by blood due to the failure.Reference report #mw5148488, #mw5148489.

• Brand Name: MEDICHOICE BLOOD TRANSFER DEVICE FOR USE WITH FEMALE LUER SYRINGE
• Common Device Name: SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.
• MDR Report Key: 18208902
• Report Number: MW5148487
• Device Sequence Number: 17704143
• Product Code: KST
• UDI-Device Identifier: 10885632136764
• UDI-Public: (01)10885632136764
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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?: No
• Device Lot Number: 2206DH02A
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown