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

Catalog Number	MZ5307
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that minibore bi-fuse pressure 2 iv connector tubing became disconnected.The following information was provided by the initial reporter: it was reported by the customer that the tubing became disconnected.
Additional Manufacturer Narrative
H.6.Investigation: two extension sets, model mz5307, was received by the customer for investigation.Upon visual inspection, it could be observed that both sets had separated at the middle connector component.The top half with the maxzeros had been returned for both sets, while only one of the lower tubing segment was returned.No other defects were observed.The customer's complaint that the tubing became disconnected easily was verified.Visual inspection under magnification was performed on both the internal and external tubing engagement components.It could be identified that the solvent had not been properly applied to the tubing during the assembly process.A device history record review for model mz5307 lot number 20126222 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The samples were sent to the manufacturing site for additional investigation.The probable root cause was determined to have been barrier of residue within the bushing machinery, preventing the application of solvent in a consistent manner around the tubing and thus, leading a low retention force or tubing disconnection failure modes.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of separation other component - no leak with lot #20126222 regarding item #mz5307.H3 other text : see h.10.
Event or Problem Description
It was reported that minibore bi-fuse pressure 2 iv connector tubing became disconnected.The following information was provided by the initial reporter: it was reported by the customer that the tubing became disconnected.

• Brand Name: MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12055215
• Report Number: 9616066-2021-51381
• Device Sequence Number: 4218519
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: 10885403230608
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/29/2021

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 Expiration Date: 12/15/2023
• Device Catalogue Number: MZ5307
• Device Lot Number: 20126222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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