MAUDE Adverse Event Report: T-CONN W/LL & 1 VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number	20041E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
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 t-conn w/ll & 1 vlv port experienced flow issues, check valve malfunction, and was clogged.The following information was provided by the initial reporter: valve malfunction, unable to inject.
Additional Manufacturer Narrative
H6: investigation summary: a 20041e product was not available for investigation; however the customer indicates that the extension set was identified to be fully occluded upon attempts to prime the set.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.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.Capa 1998036 has been initiated.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the 20041e product.
Event or Problem Description
It was reported that the t-conn w/ll & 1 vlv port experienced flow issues, check valve malfunction, and was clogged.The following information was provided by the initial reporter: valve malfunction, unable to inject.

• Brand Name: T-CONN W/LL & 1 VLV PORT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12278332
• Report Number: 9616066-2021-51707
• Device Sequence Number: 2871326
• Product Code: FPA
• UDI-Device Identifier: 27613203021665
• UDI-Public: 27613203021665
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 08/12/2021

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: 20041E
• Device Catalogue Number: 20041E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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