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

Model Number MZ5307

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

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 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 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.

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
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12502589
• MDR Text Key: 272462576
• Report Number: 9616066-2021-52091
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230606
• UDI-Public: 50885403230606
• Combination Product (y/n): N
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1