MAUDE Adverse Event Report: MICROBORE EXTENSION SET, IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9277
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint that there is fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the microbore extension set, iv connector was blocked/occluded.The following information was provided by the initial reporter: "i am having the ed rns work with the macrobore tubing that is currently in the kits used on the inpatient side to see if their concerns are addressed with this product.However, i have a new ed rn who transitioned from the inpatient side recently and she also had complaints about this tubing.".

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12339514
• Report Number: 9616066-2021-51826
• Device Sequence Number: 4441792
• Product Code: FPA
• UDI-Device Identifier: 50885403240797
• UDI-Public: 50885403240797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/26/2021

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: MZ9277
• Device Catalogue Number: MZ9277
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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