MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 6 IN NON-DEHP MICROBORE BI-FUSE SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME1001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one sample was received for quality investigation.The customers complaint of tubing defective was verified by visual inspection.Evaluation of the returned sample shows evidence of a cracked male luer at the distal end of the bi-fuse set.A device history record review could not be performed on model me1001 because a lot number was not provided by the customer.The root cause for the issues seen in this complaint is excessive force used when tightening the luer lock causing for a crack on the outer collar portion of the male luer lock assembly.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 that the screw at the top of the 6 in non-dehp microbore bi-fuse set was cracked.This complaint was created to capture the 5th of 9 related incidents.The following information was provided by the initial reporter: "the screw top at the end of the bi-fuse was found to be cracked.No leaking noticed, but was unable to get a good seal when reattaching line to picc".

• Brand Name: 6 IN NON-DEHP MICROBORE BI-FUSE SET
• 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: 11508268
• Report Number: 9616066-2021-50482
• Device Sequence Number: 2817261
• Product Code: FPA
• UDI-Device Identifier: 50885403235946
• UDI-Public: 50885403235946
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 03/10/2021

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: ME1001
• Device Catalogue Number: ME1001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1