MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.51 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33122
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 7" (18 cm) appx 0.51 ml, pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer generated a leak.The customer reported that the extension set unscrews itself when attached to a 20g piv viavalve.The issue was not detected before direct patient use.There was no clinically significant blood loss, no unprotected chemo exposure, no adverse operator consequences, and no med/surg intervention required.The device was changed out/replaced with no further problems encountered.There was no patient harm reported.
Additional Manufacturer Narrative
Five (5) new, one (1) used sample item ##mc33122, and four (4) new smiths medical viavalve (mating device) were returned for evaluation.As received an unknown solution residuals were observed on the used sample.No physical damage was confirmed on the thread for the used sample.The sample was primed and tested as per procedure with the mating device and no loose connection, leaks, or disconnections were confirmed.The male luer of the set and female luer of the matting device were within specification.Complaints of disconnection / loose connection cannot be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.51 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18422635
• Report Number: 9617594-2023-01212
• Device Sequence Number: 7964727
• Product Code: FPA
• UDI-Device Identifier: 00887709037403
• UDI-Public: (01)00887709037403(17)280301(10)13590357
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

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: 13590357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: 20G PIV VIAVALVE, UNK MFR
• Patient Sex: Unknown