MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.70 ML PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® C; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33056
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the catheter disconnecting could not be confirmed.Without the return of the sample or photo/video, an investigation could not be performed and a probable cause could not be determined.
Event or Problem Description
The event occurred on an unspecified date involving a 7" (18 cm) appx 0.70 ml pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer where the customer stated that the catheter pulls out once it¿s on.There was unknown patient involvement, unknown patient harm and unknown delay in therapy.

• Brand Name: 7" (18 CM) APPX 0.70 ML PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® C
• 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: 20320359
• Report Number: 9617594-2024-01349
• Device Sequence Number: 8147114
• Product Code: FPA
• UDI-Device Identifier: 00887709037304
• UDI-Public: (01)00887709037304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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: MC33056
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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