MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD AS LVP SS BAG 20D LOW SORB TEX; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	22602-B007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2023
Type of Reportable Event	Malfunction
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.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd as lvp ss bag 20d low sorb tex leaked.The following information was provided by the initial reporter: product leaking response received on 18-sep-2023: 1.Please describe how was the issue was first discovered? leak happened about 1 hr after the tacro bag was changed.2.Are you able to identify the location of leaking? 3.Was there any damage on the product that may have caused the leakage? no 4.What type of procedure was being performed? 5.What solution/medication was used during the incident? tacrolimus 6.Was there any patient involvement? if yes, what was the patient outcome? no harm to patient.7.Please confirm if there was any adverse event or serious injury? none 8.Please confirm the quantity of defective product inspected.One.
Event or Problem Description
It was reported that bd as lvp ss bag 20d low sorb tex leaked.The following information was provided by the initial reporter: product leaking.Response received on 18-sep-2023: 1.Please describe how was the issue was first discovered? leak happened about 1 hr after the tacro bag was changed.2.Are you able to identify the location of leaking? 3.Was there any damage on the product that may have caused the leakage? no.4.What type of procedure was being performed? 5.What solution/medication was used during the incident? tacrolimus.6.Was there any patient involvement? if yes, what was the patient outcome? no harm to patient.7.Please confirm if there was any adverse event or serious injury? none.8.Please confirm the quantity of defective product inspected.One.
Additional Manufacturer Narrative
After further review, this report was found to be a duplicate of mfr# 9616066-2023-01922.Therefore, this mdr will be cancelled.

• Brand Name: BD AS LVP SS BAG 20D LOW SORB TEX
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17814661
• Report Number: 9616066-2023-01949
• Device Sequence Number: 19418682
• Product Code: FPA
• UDI-Device Identifier: 50885403240933
• UDI-Public: (01)50885403240933
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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: Health Professional
• Device Catalogue Number: 22602-B007T
• Device Lot Number: UNKNOWN
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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