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

Model Number	40000-07T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
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 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.".
Additional 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 or Problem 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
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12541658
• Report Number: 9616066-2021-52132
• Device Sequence Number: 3990891
• Product Code: FPA
• UDI-Device Identifier: 50885403225626
• UDI-Public: 50885403225626
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790582
• 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): 10/01/2021

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 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
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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