MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, CLAVE Y-SITE, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1424228
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plumset, clave y-site, 104 inch where it was reported that there were air bubbles in the tubing during infusion.The primary tubing was primed and connected to the patient when air bubbles was noted about two inches long.The nurses replaced the tubing and attached to patient with no other issue for the rest of the infusion.It was also reported that they did not have issues with the unspecified icu med pump that was used because they were able to redo the process and changed the tubing.There was patient involved but no harm reported.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is not yet complete.
Additional Manufacturer Narrative
Received one used list #142420489, primary plumset, clave y-site, 104 inch; lot #5849387 and one used list #unknown, piercing pin and tubing; lot #unknown for evaluation.The complaint of air in line could not be confirmed.The products were attached to icu medical provided iv bags, primed per packaging directions and a flow test was performed using an icu plum pump.There were no difficulties in priming, no cassette errors, no occlusion alarms were generated, no air in line alarms were generated and no restrictions in flow were observed.There were no air bubbles observed in the fluid path.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUMSET, CLAVE Y-SITE, 104 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15065867
• Report Number: 9615050-2022-00152
• Device Sequence Number: 5614068
• Product Code: FPA
• UDI-Device Identifier: 10887787006237
• UDI-Public: (01)10887787006237(17)250301(10)5849387
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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 Expiration Date: 03/01/2025
• Device Model Number: 1424228
• Device Catalogue Number: 142420489
• Device Lot Number: 5849387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED INFUSION PUMP, ICU MED MFR
• Patient Sex: Unknown