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	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd sec set 20dp 30in w/hanger ll experienced flow issues.The following information was provided by the initial reporter: when rn went to see what was taking so long for the secondary infusion to complete rn noticed the primary was about dry from infusing and there was still drug in the secondary bag.Cqi data shows correct programming and rn confirmed physical setup was correct.Unclear why secondary bag did not empty.
Additional Manufacturer Narrative
H.6.Investigation summary: no product or photo was returned by the customer.It was reported by customer that "when rn went to see what was taking so long for the secondary infusion to complete rn noticed the primary was about dry from infusing and there was still drug in the secondary bag unclear why secondary bag did not empty" could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 72213n because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the bd sec set 20dp 30in w/hanger ll experienced flow issues.The following information was provided by the initial reporter: when rn went to see what was taking so long for the secondary infusion to complete rn noticed the primary was about dry from infusing and there was still drug in the secondary bag.Cqi data shows correct programming and rn confirmed physical setup was correct.Unclear why secondary bag did not empty.

• 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: 15820013
• Report Number: 9616066-2022-01760
• Device Sequence Number: 17312114
• Product Code: FPA
• UDI-Device Identifier: 07613203010078
• UDI-Public: 07613203010078
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/12/2022

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: Health Professional
• Device Model Number: 72213N
• Device Catalogue Number: 72213N
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/28/2022
• 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