MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	12514-01
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Section e additional reporting contact: (b)(6).
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 7" (18 cm) appx 0.45 ml, pressure infusion (400psig) ext set w/ microclave® clear, purple clamp, rotating luer.Emergency room nurses at the facility reported that this device was coming loose even after tightening them down, or it is difficult to thread/tighten down.The devices are reportedly coming undone while hand-pushing unspecified medication.There was no report of human harm.This report represents one of three occurrences.
Event or Problem Description
This emdr reflects one of three occurrences of the same reported failure mode with the same lot number.
Additional Manufacturer Narrative
The complaint on the 12514-01 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA
• 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: 19640822
• Report Number: 9617594-2024-00855
• Device Sequence Number: 20622115
• Product Code: FPA
• UDI-Device Identifier: 00887709044470
• UDI-Public: (01)00887709044470(17)290301(10)13921593
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 12514-01
• Device Lot Number: 13921593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/30/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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: UNSPECIFIED MEDICATION, MFR UNK
• Patient Sex: Unknown