MAUDE Adverse Event Report: SEC SET NO PORTS W/HANGER DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 11448964

Device Problem Improper Flow or Infusion (2954)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that sec set no ports w/hanger dehp free had back flow.The following information was provided by the initial reporter: it was reported by the customer that the secondary infusion was back flowing into primary tubing's chamber.Verbatim: date of occurrence: (b)(6) 2021.Patient's iv infusion was set up as a secondary infusion.Primary tubing was primed with ns and secondary tubing was connected to ordered medication.Once infusion was started and tubing was unclamped, this nurse noted secondary infusion was back flowing into primary tubing's chamber instead of infusing into patient.All tubing was clamped before primary tubing's chamber had filled, preventing medication from completely back-filling into ns bag.Requested second nurse to assist in trouble-shooting.Unable to determine cause of improper flow.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that the secondary infusion was back flowing into primary tubing's chamber.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0007 lot number 21029010 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 11feb2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 11448964 lot number 21039546 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 11mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.H3 other text : see h10.

Event Description

It was reported that sec set no ports w/hanger dehp free had back flow.The following information was provided by the initial reporter: it was reported by the customer that the secondary infusion was back flowing into primary tubing's chamber.Verbatim: date of occurrence: (b)(6) 2021 patient's iv infusion was set up as a secondary infusion.Primary tubing was primed with ns and secondary tubing was connected to ordered medication.Once infusion was started and tubing was unclamped, this nurse noted secondary infusion was back flowing into primary tubing's chamber instead of infusing into patient.All tubing was clamped before primary tubing's chamber had filled, preventing medication from completely back-filling into ns bag.Requested second nurse to assist in trouble-shooting.Unable to determine cause of improper flow.

• Brand Name: SEC SET NO PORTS W/HANGER DEHP FREE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12337673
• MDR Text Key: 267112157
• Report Number: 9616066-2021-51822
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• 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: 09/07/2021

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: 03/10/2024
• Device Catalogue Number: 11448964
• Device Lot Number: 21039546
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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