MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET SMALLBORE TBG W/4 FEMALE LL; INTRAVASCULAR ADMINISTRATION SET

Model Number	10015817
Medical Device Problem Codes	Backflow (1064); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2020
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 customer complaint of tubing defective was verified by visual inspection.Upon review of the submitted sample a clear crack in the female luer adapter can be seen.A device history record review could not be performed on model 10015817 because a lot number was not provided by the customer.The root cause for the failure seen is a component failure due to excessive force applied to the female luer adapter.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 ext set smallbore tbg w/4 female ll hub cracked after connecting the tubing, which allowed blood to back up into it and leak out.This complaint was created to capture the 3rd of 9 related incidents.The following information was provided by the initial reporter: hub cracked on minutes after connecting new tubing to the red lumen of the picc tonight, blood began to back up in the tubing and leak through a connection.I immediately clamped the lumen and asked for assistance in troubleshooting.It appears that there was a crack in the connection between the quad fuse and the pressure tubing leading to the cvp transducer.

• Brand Name: EXT SET SMALLBORE TBG W/4 FEMALE LL
• 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: 11499480
• Report Number: 9616066-2021-50472
• Device Sequence Number: 2857281
• Product Code: FPA
• UDI-Device Identifier: 50885403234055
• UDI-Public: 50885403234055
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/10/2021

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: 10015817
• Device Catalogue Number: 10015817
• 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: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1