MAUDE Adverse Event Report: SEC W/SS DC 20DP & HANGER TEX; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10013364T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: actual lot number is unknown, however the customer suspects lots 21069692 (mfg: 06/22/2021 exp: 06/23/2023) and 21069690 (mfg: 06/08/2021 exp: 06/21/2024).Investigation summary: no product or photo was returned by the customer.The customer complaint of separation at drip chamber could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.The lot number is reported as unknown, but a possible lot numbers were given.A device history record review for the provided model number and potential lot numbers was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build for each set.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 4 sec w/ss dc 20dp & hanger tex had issues with component separation.The following information was provided by the initial reporter: "we¿ve been seeing an increased frequency of leaks due to the tubing that attaches at the bottom of the drip chamber coming free entirely.It looks like the sonic welds or whatever means of attachment being used is failing at a higher than usual rate.".

• Brand Name: SEC W/SS DC 20DP & HANGER TEX
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12629368
• Report Number: 9616066-2021-52221
• Device Sequence Number: 11834714
• Product Code: FPA
• UDI-Device Identifier: 10885403221927
• UDI-Public: 10885403221927
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 09/15/2021

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: 10013364T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/14/2021
• 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