MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SEC SET 20DP 30IN W/HANGER LL; INTRAVASCULAR ADMINISTRATION SET

Model Number	72213N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address information was not able to be obtained, therefore, nj was used as a place holder.One sample of material number 72213n was received for quality investigation.The customer complaint of component damage - leakage at connector could not be verified by investigation.Initial evaluation of the sample was conducted by visually inspecting each of the components of the assembly.The assembly looked to be correct without signs of damage to any of the components.Based on the customers description, the distal male luer connector was further examined for damage or signs of leakage or breakage.The male luer connection was measured for length of the body and compared to its construction drawing.The dimension of the luer body was within specification of the construction drawing.The luer was then examined under magnification to see if the body showed signs of damage due to the customers claim that the tip of the construction broke off.Under magnification there was no signs of breakage of the luer tip (photo attached).Finally the luer was connected to a sample smartsite and primed with an iv bag with saline solution.The assembly was primed with the saline solution and the end was closed off with a sample stopcock.The infusion bag was raised to a height of 24 inches above the outlet of the assembly and allowed to sit for 15 minutes and observed for any leakage at the luer connection location.There were no signs of leakage or any other further issues.A device history record review for model 72213n lot number 22039069 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause was not determined because the reported failure could not be verified or replicated.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 bd sec set 20dp 30in w/hanger ll leaking at the junction end.The following information was provided by the initial reporter: report of leaking at the junction end.
Event or Problem Description
It was reported that the bd sec set 20dp 30in w/hanger ll leaking at the junction end.The following information was provided by the initial reporter: report of leaking at the junction end.
Additional Manufacturer Narrative
The following fields were updated due to corrections: h.6.Imdrf annex g grid: g04034, h.6.Imdrf annex b grid: b01, b11, b14, h.6.Imdrf annex c grid: c19, h.6.Imdrf annex d grid: d14.

• Brand Name: BD SEC SET 20DP 30IN W/HANGER 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15795022
• Report Number: 9616066-2022-01728
• Device Sequence Number: 19585864
• Product Code: FPA
• UDI-Device Identifier: 07613203010078
• UDI-Public: (01)07613203010078
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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,Followup
• Report Date (Section B): 11/16/2022

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: 03/04/2025
• Device Model Number: 72213N
• Device Catalogue Number: 72213N
• Device Lot Number: 22039069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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
• Patient Sex: Unknown