MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D LOW SORB 2SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME1055
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris¿ lvp 20d low sorb 2ss 0.2m cv experienced a loose iv set connection, and leakage.The following information was provided by the initial reporter: when you remove the cap the tubing sticks a little and you have to move it around the part that connects to the iv before connecting it.
Event or Problem Description
It was reported that the bd alaris¿ lvp 20d low sorb 2ss 0.2m cv experienced a loose iv set connection, and leakage.The following information was provided by the initial reporter: when you remove the cap the tubing sticks a little and you have to move it around the part that connects to the iv before connecting it.
Additional Manufacturer Narrative
H6: investigation summary two samples were received for quality investigation.The customer complaint of connection issues was verified by investigation.One of the samples submitted did not have have a blue cap on the female luer adapter and the other sample did have a blue luer adapter cap attached to the tubing.Visual examination of the sample submitted did not indicate any issues with the extension sets.The sets were then attempted to be primed.When attempting to prime the extension set with the blue cap connected, it was noticed that the blue cap was connected very tightly.It took a great amount of torque to disconnect the blue luer cap.When the blue cap was removed priming of the tubing was possible without signs of leakage, air-in-line or occlusion of the tubing.The blue cap was then reassembled to the extension set but did not screw on tightly.The blue cap would spin to the point where it felt like it would stop but then spin past the stopping point and become loose again.Further examination of the threads of the female luer adapter and luer cap do not show any damage to either surface.A device history record review for model me1055 lot number 22059337 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24may2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this place is undetermined.Based on the findings of the investigation, the probable root cause for the issue seen in this complaint is that the blue luer cap was installed too tightly during the assembly process.The manufacturing facility was made aware of the failure and a quality notification was issued in order to correct this issue.

• Brand Name: BD ALARIS¿ LVP 20D LOW SORB 2SS 0.2M CV
• 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: 15602028
• Report Number: 9616066-2022-01547
• Device Sequence Number: 11296886
• Product Code: FPA
• UDI-Device Identifier: 10885403236020
• UDI-Public: 10885403236020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/21/2022

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: 01/06/2025
• Device Model Number: ME1055
• Device Catalogue Number: ME1055
• Device Lot Number: 22019161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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