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

Model Number	2232-0007
Medical Device Problem Codes	Leak/Splash (1354); Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd gem v/nv 20d 0.2 fltr experienced air in line, and component separation.The following information was provided by the initial reporter: connected new large bore iv tubing to patient piv.Pump alarmed air in line.When i opened up iv channel and gently took out tubing to check the "air", the tubing came apart and fluids went everywhere.Tubing was hung earlier that same day.No other treatment of follow-up was necessary outside of getting new tubing set up.The defective product has been saved for evaluation.
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of separation near the pumping segment and a resultant leak 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 2232-0007 because a valid lot number was not provided by the customer.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-01-04.H6: investigation summary the customer reported they gently removed the tubing from the pump and it fell apart.There was one used sample of material #2232-0007 returned.The sample was clearly separated at the lower fitment, and the complaint is verified.The root cause was found to be insufficient solvent.No other failure modes were observed.A device history record review could not be performed on model 2232-0007 because a valid lot number was not provided by the customer.H3 other text : see h10.
Event or Problem Description
It was reported that the bd gem v/nv 20d 0.2 fltr experienced air in line, and component separation.The following information was provided by the initial reporter: connected new large bore iv tubing to patient piv.Pump alarmed air in line.When i opened up iv channel and gently took out tubing to check the "air", the tubing came apart and fluids went everywhere.Tubing was hung earlier that same day.No other treatment of follow-up was necessary outside of getting new tubing set up.The defective product has been saved for evaluation.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12959818
• Report Number: 9616066-2021-52548
• Device Sequence Number: 1728366
• Product Code: FPA
• UDI-Device Identifier: 50885403463967
• UDI-Public: 50885403463967
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 01/28/2022

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 Model Number: 2232-0007
• Device Catalogue Number: 2232-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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