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	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Event or Problem Description
The event involved a 7" (18 cm) appx 0.51 ml, pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer where it was reported that the extension set mc33122 unscrews itself when attached to a 20g piv viavalve.The event occurred during infusion.There was no clinically significant blood loss, no unprotected chemo exposure, no adverse operator consequences, no med/surg intervention required.The device was changed out/replaced with no further problems encountered.There was patient involvement, no serious injury/death, and there was delay in therapy.
Additional Manufacturer Narrative
Received: two new.List #mc33122, 7" (18 cm) appx 0.51 ml, pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer; lot #13716438 two new.List #mc33122, 7" (18 cm) appx 0.51 ml, pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer; lot #13738336.Two new.List #mc33122, 7" (18 cm) appx 0.51 ml, pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer; lot #13722761.Six (6) new samples item ##mc33122 were returned for evaluation.As received no physical damage or anomalies were confirmed on the brand-new samples.No mating device was returned for evaluation.The samples were primed and tested as per procedure and no loose connection, leaks or disconnections were confirmed.The male luer of the sets were within specification.Complaint 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: 18362974
• Report Number: 9617594-2023-01186
• Device Sequence Number: 18120802
• Product Code: FPA
• UDI-Device Identifier: 00887709037403
• UDI-Public: (01)00887709037403(17)280701(10)13716438
• 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,Followup
• Report Date (Section B): 01/15/2024

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: 13716438
• 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
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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 PERIPHERAL IV VIAVALVE, UNK MFR.
• Patient Sex: Unknown