MAUDE Adverse Event Report: 9.5 INCH EXT W/1 VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number 30201E

Device Problem Partial Blockage (1065)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the 9.5 inch ext w/1 vlv port was blocked during the flush.The following information was provided by the initial reporter: "posiflush unable to flush through extension set.Nurse has to fiddle with tubing as it felt like a blockage.".

Event Description

It was reported that the 9.5 inch ext w/1 vlv port was blocked during the flush.The following information was provided by the initial reporter: "posiflush unable to flush through extension set - nurse has to fiddle with tubing as it felt like a blockage.".

Manufacturer Narrative

H.6.Investigation: a 30201e product was not available for investigation; however the customer confirmed that the complaint sample was from lot 20126447.No additional information was available to assist the investigation in this instance.A review of the production records for lot 20126447 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.H3 other text : see h.10.

• Brand Name: 9.5 INCH EXT W/1 VLV PORT
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12243086
• MDR Text Key: 264062545
• Report Number: 9616066-2021-51639
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203011564
• UDI-Public: 37613203011564
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2023
• Device Model Number: 30201E
• Device Catalogue Number: 30201E
• Device Lot Number: 20126447
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 07/29/2021
• Supplement Dates FDA Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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