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

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation.Investigation is pending.

Event 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.

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®
• Type of Device: 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
• MDR Text Key: 331358307
• Report Number: 9617594-2023-01186
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709037403
• UDI-Public: (01)00887709037403(17)280701(10)13716438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 20G PERIPHERAL IV VIAVALVE, UNK MFR.