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/REMV MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33122
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unknown date involving a 7" (18 cm) appx 0.45 ml, pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer.It was stated on the report that there is a high rate infusions that are causing the device to pop off of the iv catheter.One came apart during an iv antibiotic infusion and part of the medication was lost.There was patient involved and unknown human harm.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.
Additional Manufacturer Narrative
The complaint of disconnection / loose connection on item mc33122 cannot be confirmed.Since 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 probable cause cannot be determined.Lot history review couldn't be performed due to the lot number for this complaint was unknown.

• Brand Name: 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®
• 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: 20077622
• Report Number: 9617594-2024-01213
• Device Sequence Number: 15415805
• Product Code: FPA
• UDI-Device Identifier: 00887709037403
• UDI-Public: 00887709037403
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/02/2024

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: MC33122
• Device Lot Number: UNKNOWN
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/02/2024
• 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