MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM 20DP 0.2MF LOW SORBING DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	2465-0007
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 gem 20dp 0.2mf low sorbing dehp free was clogged/blocked/occluded.The following information was provided by the initial reporter: "occluded during infusion.".
Event or Problem Description
It was reported gem 20dp 0.2mf low sorbing dehp free was clogged/blocked/occluded.The following information was provided by the initial reporter: "occluded during infusion".
Additional Manufacturer Narrative
H.6.Investigation: one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to an iv bag filled with normal saline.No flow was happening while all clamps were in the open position.A syringe was attached to the end of the set in an attempt to primed.The set was able to be forcibly primed but still would not flow using gravity.A quality notification was sent to the supplier.The supplier investigation confirmed a slower than expected flow through the filter but was unable to determine the root cause of the slow flow.A device history record review for model 2465-0007 lot number 20106499 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - fluid blockage with lot #20106499 regarding item #2465-0007.H3 other text : see h.10.

• Brand Name: GEM 20DP 0.2MF LOW SORBING DEHP FREE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12523083
• Report Number: 9616066-2021-52123
• Device Sequence Number: 5338372
• Product Code: FPA
• UDI-Device Identifier: 50885403221949
• UDI-Public: 50885403221949
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 10/19/2023
• Device Model Number: 2465-0007
• Device Catalogue Number: 2465-0007
• Device Lot Number: 20106499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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