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	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If additional information becomes available a supplemental report will be submitted.Additional contact person from ufmw ¿ (b)(4).Due to a system limitation, the date received is inadvertently marked as 3/10/2021 for this initial emdr.The correct date is 3/9/2021.
Event or Problem Description
A medsun mandatory medwatch report was received that stated "a lot of air found between pointy end of filter and tubing.Patient's peripherally inserted central catheter (picc) line tubing has been having issues with air bubbles for the past few days.Troubleshooting by rn transport specialist (rnts) 2 days ago and iv pump was changed.No leaks or break in line.Chamber noted to be full, rn emptied half of chamber and was able to flick all of the air bubbles up towards chamber.Consider use of different tubing if available.Part of larger air in line trend.This air seems lower than others reported and may be more associated with defective filter - this patient has also had repeated blood back up issues that are believed to be associated with a filter problem¿.The event occurred in the patient's room at the hospital.There was patient involvement and no patient harm was reported.

• 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: 11615894
• Report Number: 9617594-2021-00111
• Device Sequence Number: 3125000
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO