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 Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris¿ lvp 20d low sorb 2ss 0.2m cv the tubing clamp was didn't move.There was no report of patient impact.The following information was provided by the initial reporter: material #: me1055, batch #: 22059338.It was reported by the customer that the new luer lock connection no longer slides or moves.Verbatim: me1055 the luer lock connection no longer slides or moves.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval: yes.D.10.Returned to manufacturer on: 18-aug-2022.H.6.Investigation summary: one sample of extension set me1055 was received for quality investigation.The customer complaint of adaptor/connector defective/ damaged was not verified.Visual examination of the sample did not indicate any damage to the assembly.The male luer connector was then examined for cracks or damage.No damage was identified.The connector was then connected to an extension set and fluid was pushed through the extension set using a syringe.There was no visual leakage, air-in-line or occlusion issues identified.The connector was then tested for connection and disconnection.The securement collar operated as expected and there were no issues with connection or disconnection.The build of materials for the extension set assembly was also cross checked with the sample to verify that the correct component was installed.A device history record review for model me1055 lot number 22059338 was performed.The search showed that a total of 19,203 units in 1 lot number was built on 24may2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined based on the failure mode not being recreated during testing.
Event or Problem Description
It was reported while using bd alaris¿ lvp 20d low sorb 2ss 0.2m cv the tubing clamp was didn't move.There was no report of patient impact.The following information was provided by the initial reporter: material #: me1055 batch #: 22059338.It was reported by the customer that the new luer lock connection no longer slides or moves.Verbatim: me1055 the luer lock connection no longer slides or moves.

• 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: 15341552
• Report Number: 9616066-2022-01267
• Device Sequence Number: 5221736
• Product Code: FPA
• UDI-Device Identifier: 10885403236020
• UDI-Public: 10885403236020
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/02/2022

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: 05/24/2025
• Device Model Number: ME1055
• Device Catalogue Number: ME1055
• Device Lot Number: 22059338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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