MAUDE Adverse Event Report: SEC 20DP, TEXIUM & HANGER V/NV; INTRAVASCULAR ADMINISTRATION SET

Model Number 40000-07T

Device Problem Material Separation (1562)

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

Event Date 08/31/2021

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 two sec 20dp, texium & hanger v/nv had component separation issues.The following information was provided by the initial reporter: "i have 2 more texium secondary sets that came apart like the others.".

Manufacturer Narrative

H.6.Investigation: the customer reported the product came apart and returned two used samples of material #40000-07t.The samples were clearly separated below the drip chamber, and the complaint is verified.The root cause for the separation is insufficient solvent applied during assembly.This issue has been ongoing and manufacturing has made corrective actions to address the issue.These include a project to update the solvent applicator optimal screw depth specification and preparation, as well as balancing the manufacturing cell operations.A device history record review could not be performed on model 40000-07t because a valid lot number was not provided by the customer.H3 other text : see h.10.

Event Description

It was reported two sec 20dp, texium & hanger v/nv had component separation issues.The following information was provided by the initial reporter: "i have 2 more texium secondary sets that came apart like the others.".

• Brand Name: SEC 20DP, TEXIUM & HANGER V/NV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12541658
• MDR Text Key: 273621104
• Report Number: 9616066-2021-52132
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403225626
• UDI-Public: 50885403225626
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• 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: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 40000-07T
• Device Catalogue Number: 40000-07T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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