MAUDE Adverse Event Report: MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5307
Medical Device Problem Codes	Backflow (1064); Complete Blockage (1094); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that minibore bi-fuse pressure 2 iv connector came apart, leaked, and had flow issues.The following information was provided by the initial reporter: material no: mz5307, batch no: unknown.[event 4] it was reported that tubing popped at y-site causing the line to bleed back and clot off.The attempt to aspirate was unsuccessful.
Additional Manufacturer Narrative
H.6.Investigation: the customer reported the tubing popped at the y-site, and returned one used sample of model #mz5307.The sample was clearly separated at the y-site and the complaint is verified.The solvent depth was very shallow.The inability to aspirate was not verified due to the sample being compromised.No other failure modes were observed.A device history record review could not be performed because a valid lot number was not provided by the customer.Visual inspection under the microscope found the root cause to be insufficient solvent.
Event or Problem Description
It was reported that minibore bi-fuse pressure 2 iv connector came apart, leaked, and had flow issues.The following information was provided by the initial reporter: material no: mz5307 batch no: unknown [event 4] it was reported that tubing popped at y-site causing the line to bleed back and clot off.The attempt to aspirate was unsuccessful.

• Brand Name: MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 11853571
• Report Number: 9616066-2021-51074
• Device Sequence Number: 4017339
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: 10885403230608
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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
• Operator of Device: Other
• Device Catalogue Number: MZ5307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 10/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1