MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. T-CONN W/LL & 1 VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number	20041E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a 20041e sample was received for investigation of pr 2776617 with residual fluid in the line; no packaging was received with the sample, however the customer indicates the affected lot number to be 20125847.A visual inspection confirmed the customer's experience as the smartsite had separated from the tubing joint of the 20041e sample; a close inspection of the separated tubing identified some residual solvent at the tubing joint.The details of this feedback were forwarded to the manufacturing site for investigation.A definitive root cause for the separation could not be determined in this instance; however it is possible that an inconsistent amount of solvent had been applied to the joint during the assembly process.This is a manual process and is likely to have occurred due to human error.A review of the production records for lot 20125847 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with this customer being the only customer to provide this type of feedback against the 20041e in the past 12 months.
Event or Problem Description
It was reported that the t-conn w/ll & 1 vlv port tubing was defective and separated in the packaging.The following information was provided by the initial reporter: "the user found broken tube in the package".

• Brand Name: T-CONN W/LL & 1 VLV PORT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 11838907
• Report Number: 9616066-2021-51045
• Device Sequence Number: 4688987
• 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
• Report Date (Section B): 05/03/2021

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 Expiration Date: 12/15/2023
• Device Model Number: 20041E
• Device Catalogue Number: 20041E
• Device Lot Number: 20125847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1