MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 126" 10 DROP PRIMARY SET W/3 MICROCLAVE®, 2 GANG 4-WAY STOPCOCKS, ROTATING LUER,; STOPCOCK, I.V. SET

Catalog Number	Z3239
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 126" 10 drop primary set w/3 microclave¿, 2 gang 4-way stopcocks, rotating luer, 1 ext.The customer initially reported that the tubing would not flow, the intravenous (iv) patient blood returned; the iv tubing was replaced.Additional information became available via a medsun medwatch mandatory report uf/importer report # (b)(4).Which stated: " in pre-operation, anesthesia tubing was noted to not be flowing.Anesthesia tubing would not flow.Peripheral intravenous (piv) was patent with positive blood return.Iv tubing replaced and ivf flowing freely.No reported patient harm and only ivf medication noted to be running, not anesthetic medication." the date of the event submitted on the medwatch was (b)(6) 2023.There was patient involvement, but no harm was reported as a consequence of this event.
Additional Manufacturer Narrative
The customer returned a used z3239 primary set was returned for investigation.It was observed that the inline check valve had been assembled backwards which would prevent fluid flow past the check valve.The probable cause of occluded flow during priming is a misassembled check valve during manual assembly in manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.E1 - additional contact name: (b)(6).

• Brand Name: 126" 10 DROP PRIMARY SET W/3 MICROCLAVE®, 2 GANG 4-WAY STOPCOCKS, 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18092098
• Report Number: 9617594-2023-00952
• Device Sequence Number: 5945650
• Product Code: FMG
• UDI-Device Identifier: 00887709030473
• UDI-Public: (01)00887709030473(17)270801(10)8359935
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 11/08/2023

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: Z3239
• Device Lot Number: 8359935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: ADMINISTRATION TUBING, MFR UNK.; IN VITRO FERTILIZATION MEDICATION, MFR UNK.; PERIPHERAL IV, MFR UNK.
• Patient Sex: Unknown