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

Model Number	MZ5307
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the minibore bi-fuse pressure 2 iv connector experienced component separation.The following information was provided by the initial reporter: a mini bore bi-fuse had the main tubing (before it splits into two smaller lumens) separate from the distal segment where it inserts into the patient.
Event or Problem Description
It was reported that the minibore bi-fuse pressure 2 iv connector experienced component separation.The following information was provided by the initial reporter: a mini bore bi-fuse had the main tubing (before it splits into two smaller lumens) separate from the distal segment where it inserts into the patient.
Additional Manufacturer Narrative
H.6.Investigation: one used bifuse extension set, model mz5307, was received by the customer for investigation.Upon visual inspection, it could be observed that the set's y parallel connector was disconnected from the tubing.No other defects were observed.The customer's complaint that the tubing separated from the distal segment was verified.Visual inspection under magnification was performed on both the internal and external tubing engagement components.It could be identified that an insufficient amount of solvent had been applied to the tubing during the assembly process.A device history record review could not be performed on model mz5307 because a lot number was not provided by the customer.H3 other text : see h.10.

• Brand Name: MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12502589
• Report Number: 9616066-2021-52091
• Device Sequence Number: 3398584
• Product Code: FPA
• UDI-Device Identifier: 50885403230606
• UDI-Public: 50885403230606
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/21/2021

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 Model Number: MZ5307
• Device Catalogue Number: MZ5307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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