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 Codes	Disconnection (1171); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2024
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.
Event or Problem Description
It was reported that a 7" (18 cm) appx 0.45 ml, pressure infusion (400psig) ext set w/ microclave® clear, purple clamp, rotating luer was found to have disconnected during patient use.The reporter stated that they were having trouble with their extension sets since it was not connecting correctly or coming unconnected.There was no patient harm reported.
Additional Manufacturer Narrative
The complaint on the 12514-01 device 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 non conformities were found that would have led to the reported complaint.Additional/updated information can be found in b5, d9, d10, e4 and h6.
Event or Problem Description
Additional information was received stating that patient (b)(6) was involved in the event.It was also stated that they were not able to inject correct amount of contrast and the nurse assured that the connector was hooked up properly and tight.There was patient involvement, no human harm or adverse event and no delay in therapy reported.

• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20452382
• Report Number: 9617594-2024-01450
• Device Sequence Number: 17903696
• Product Code: FPA
• UDI-Device Identifier: 00887709044470
• UDI-Public: (01)00887709044470(17)290601(10)14041042
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 14041042
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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 CONTRAST INFUSATE, MFR UNK.
• Patient Sex: Unknown