MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LU; STOPCOCK, I.V. SET

Catalog Number	Z0792
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The incident involved a 8" (20cm) appx 0.48ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer on an unknown date.It was reported that the customer had a report of a total parenteral nutrition (tpn) filter occlusion in the neonatal intensive care unit (nicu).There was patient involvement and unknown human harm.This is the third of three reports.
Additional Manufacturer Narrative
The used z0792 extension set assembly was able to be primed and leak tested without difficulty or leakage.The complaint was unable to be replicated or confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LU
• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17744221
• Report Number: 9617594-2023-00706
• Device Sequence Number: 4236366
• Product Code: FMG
• UDI-Device Identifier: 00887709021822
• UDI-Public: (01)00887709021822(17)271101(10)11756876
• 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: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: Health Professional
• Device Catalogue Number: Z0792
• Device Lot Number: 11756876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: TPN, MFR UNK
• Patient Sex: Unknown