MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD GEM V/NV 20D 0.2 FLTR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2232-0007
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 that bd gem v/nv 20d 0.2 fltr was clogged.The following information was provided by the initial reporter with the verbatim: rn was setting up her iv tubing when the priming fluids wouldn't move throughout the tubing.The tubing was unclamped.The fluid was not moving through the iv tubing despite being unclamped.Rn called her charge nurse, rn to evaluate and said that the tubing may have been defective since it was not moving despite being unclamped.Unable to prime pump infusion set.
Event or Problem Description
It was reported that bd gem v/nv 20d 0.2 fltr was clogged.The following information was provided by the initial reporter with the verbatim: rn was setting up her iv tubing when the priming fluids wouldn't move throughout the tubing.The tubing was unclamped.The fluid was not moving through the iv tubing despite being unclamped.Rn called her charge nurse, rn to evaluate and said that the tubing may have been defective since it was not moving despite being unclamped.Unable to prime pump infusion set.
Additional Manufacturer Narrative
H6: investigation summary one sample model 2232-0007, lot 21125446 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a iv bag filled with water and primed using gravity.The customer complaint that they could not prime the set was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 2232-0007 lot number 21125446 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD GEM V/NV 20D 0.2 FLTR
• 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: 17738323
• Report Number: 9616066-2023-01880
• Device Sequence Number: 6615256
• Product Code: FPA
• UDI-Device Identifier: 10885403463969
• UDI-Public: (01)10885403463969
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 10/19/2023

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: 12/22/2024
• Device Catalogue Number: 2232-0007
• Device Lot Number: 21125446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2021
• 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