MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y MICROBORE EXT W/LUER & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number	10794983
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 20095142.Medical device expiration date: 2023-09-18.Device manufacture date: 2020-08-26.Medical device lot #: 20095141.Medical device expiration date: 2023-09-17.Device manufacture date: 2020-08-26.Medical device lot #: 20036894.Medical device expiration date: 2023-03-25.Device manufacture date: 2020-03-23.Investigation summary: one photo sample was submitted for quality investigation.The customer complaint of component damage was verified through a submitted photo.The component damage identified was a separation of the tubing from the male luer lock.A device history record review could not be performed on model 10794983 because a lot number was not provided by the customer.Due to no sample being received, a root cause could not be determined.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 y microbore ext w/luer & 2 sld clp tubing snapped off below the male luer connection to the phaseal set.This occurred once each in lots 20095142, 20095141, 20036894, and an unspecified lot.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: "received patient at start of shift with pac infusing.5 port ivf tubing connected to bifurcate extension, connected to phaseal, connected to heparin cap and patient's pac.Shortly after bifurcate extension set found broken with tubing snapped below male connection.Male connection remained attached to phaseal.Female connection intact with ivf tubing.".

• Brand Name: Y MICROBORE EXT W/LUER & 2 SLD CLP
• 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: 11458167
• Report Number: 9616066-2021-50427
• Device Sequence Number: 3705654
• Product Code: FPA
• UDI-Device Identifier: 50885403234291
• UDI-Public: 50885403234291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 03/04/2021

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: 10794983
• Device Catalogue Number: 10794983
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1