MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	MC9079
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) used list# mc9079, 17" ext set w/0.2 micron filter, microclave® clear, clamp, rotating luer (lot# 4915987) was received and visually inspected.As received, the inlet and outlet filter vents were slightly wetted out, or saturated with prior infusate.No other visible damage, or anomalies were identified.No mating devices were returned.The single used extension set was primed with water at gravity pressure, and then leak tested.No leaks, or air bubbles were seen.The reported complaint could not be confirmed, or replicated.A device history review for lot# 4915987, and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.Additional reporter information: (b)(6).
Event or Problem Description
User facility medwatch report was received and stated the following: air bubbles present between filter and patient.I was changing hal (hyperalimentation) and il (intravenous) lines infusing through a picc line.I had primed the tubing, checked for and dispelled air bubbles in the line.Once the line was attached to the patient, air bubbles developed between the filter and the patient.The infusion was immediately stopped, a new filter was primed and reattached to the patient.Again air bubbles appeared in the same area of the line.Another rn then primed a whole new line, no further air bubbles noted.The remaining stock of filters of that lot number were pulled for testing.The original intended procedure was iv infusion.The problem that the user have was device failure (e.G.Broke, couldn¿t get it to work or stopped working).There was patient involvement, but no harm reported.This report is for the first of two devices.

• Brand Name: 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10777105
• Report Number: 9617594-2020-00470
• Device Sequence Number: 14366708
• Product Code: FMG
• UDI-Device Identifier: 00887709078161
• UDI-Public: (01)00887709078161(17)250601(10)4915987
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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: 06/01/2025
• Device Model Number: MC9079
• Device Catalogue Number: MC9079
• Device Lot Number: 4915987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HYPERALIMENTATION, UNK MFG; PICC LINE
• Patient Age: 2 MO