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	Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris¿ lvp 20d low sorb 2ss 0.2m cv the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: we have been using bd maxguard extension set ref #me1055 for a long time.We noticed that the new batches are different with the leur lock not sliding back as it used to be.Previous model lot #20045474, current lot #23029011.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of luer lock not no product or photo was returned by the customer.The customer complaint of adapter/ connector defective/ damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model me1055 lot number 23029011 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.A review of the male luer connector has determined that it is constructed within its design parameters.The male luer connector design does not allow for the securement collar to travel freely on the tubing set, and now sits in a groove on the male luer body.
Event or Problem Description
It was reported while using bd alaris¿ lvp 20d low sorb 2ss 0.2m cv the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: we have been using bd maxguard extension set ref #me1055 for a long time.We noticed that the new batches are different with the leur lock not sliding back as it used to be.Previous model lot #20045474, current lot #23029011.

• 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 ; 8448235433
• MDR Report Key: 17114391
• Report Number: 9616066-2023-01160
• Device Sequence Number: 6649471
• Product Code: FPA
• UDI-Device Identifier: 10885403236020
• UDI-Public: (01)10885403236020
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 06/21/2023

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: 02/01/2026
• Device Model Number: ME1055
• Device Catalogue Number: ME1055
• Device Lot Number: 23029011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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