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

Catalog Number	MZ5307
Medical Device Problem Codes	Backflow (1064); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2020
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 leaked and had blood backflow.The following information was provided by the initial reporter: material no: mz5307 batch no: unknown.[event 3] it was reported that medication was leaking and blood backed up into the cap.And on the y-connector into the tubing.
Event or Problem Description
It was reported that minibore bi-fuse pressure 2 iv connector leaked and had blood backflow.The following information was provided by the initial reporter: material no: mz5307 batch no: unknown.[event 3] it was reported that medication was leaking and blood backed up into the cap.And on the y-connector into the tubing.
Additional Manufacturer Narrative
H.6.Investigation: the customer reported that blood backed up into the tubing and was leaking, then returned one used sample of model #mz5307 with two additional used filter sets of material #mz9226.The tubing leaked from a crack in the middle of one of the filters, and the blood backing up and leakage complaints were verified.The root cause is unknown at this time.The filter was investigated further by the supplier, who was unable to test them due to the blood contamination.An assortment of filters, that were also cracked in the middle, and that were not contaminated with blood, were sent to the supplier and the root cause could not be determined for these either.A device history record review could not be performed because a valid lot number was not provided by the customer.Even without the blood contamination, the root cause would be unknown from the supplier investigation.H3 other text : see h.10.

• Brand Name: MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 11853570
• Report Number: 9616066-2021-51073
• Device Sequence Number: 4017338
• 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: 09/23/2021
• 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