MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV CLAVE¿, PURP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	Z3848
Medical Device Problem Codes	Crack (1135); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.
Event or Problem Description
The complaint/event involved a 7" (18 cm) appx 0.43 ml, pressure infusion (400psig) ext set w/remv clave¿, purple clamp, luer lock.The clave connection reportedly disengaged from the bifuse location to that patient's iv (intravenous) line connector due to a crack on the luer lock ring.The bifuse needed to be replaced and the patient was briefly without ivfs (intravenous fluids).There was no report of human harm associated with this event/complaint.
Additional Manufacturer Narrative
No z3848 product samples, videos, or photographs were returned for investigation.The dhr was not reviewed, and no lot number information was provided.A probable cause cannot be identified based on the information that has been provided.The device history review (dhr) was not reviewed, and no lot number information was provided.

• Brand Name: 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV CLAVE¿, PURP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 20388739
• Report Number: 9617594-2024-01388
• Device Sequence Number: 8008665
• Product Code: FPA
• UDI-Device Identifier: 00887709059443
• UDI-Public: 00887709059443
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: Z3848
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED IV LINE WITH CONNECTOR, MFR UNK.
• Patient Sex: Unknown