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

Model Number	30201E
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12243086
• Report Number: 9616066-2021-51639
• Device Sequence Number: 17046905
• Product Code: FPA
• UDI-Device Identifier: 37613203011564
• UDI-Public: 37613203011564
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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