MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60IN/152.4CM EXT. W/M/FLL CLAMP APV=1.0ML; STOPCOCK, I.V. SET

Catalog Number	536035
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.
Event or Problem Description
The event involved a 60in/152.4cm ext.W/m/fll clamp apv=1.0ml where it was reported their team was experiencing some safety issues with the device.They had issues of high-pressure alerts on their medfusion pumps on a few of their patients.Upon their assessment, all of the patients had been infusing via the icu medical (1.1 ml priming volume 60-inch tubing).There was patient involvement but not harm reproted.

• Brand Name: 60IN/152.4CM EXT. W/M/FLL CLAMP APV=1.0ML
• 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: 18253336
• Report Number: 9617594-2023-01057
• Device Sequence Number: 7191510
• Product Code: FMG
• UDI-Device Identifier: 00887709125803
• UDI-Public: (01)00887709125803(17)280601(10)13674421
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/02/2023

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: 536035
• Device Lot Number: 13674421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 12/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Patient Sex: Unknown