MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MC33150

Device Problem Disconnection (1171)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

The incident involved a 7" (18cm) appx 0.24ml, smallbore pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer.It was reported that the extension is coming unattached from the catheter hub when computed tomography (ct) contrast is being injected.There was patient involved, no patient harm reported but there was delay in therapy as the patient did not receive all the iv contrast they were supposed to get.

Manufacturer Narrative

One (1) used sample, #mc33150 connected with a used catheter was returned for evaluation.A solution residual was observed on the sample and the mating device.The set was primed and tested as procedure and no leaks, occlusions or anomalies were confirmed.The male luer (device) and the female luer (mating device) were measured and were within specification.The complaint of disconnection / loose connection was not able to confirmed or replicated.However, residual solution on the device indicates that a leak occurred.The probable cause of the leaks observed between the male luer and catheter cannot be determined.

• Brand Name: 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV
• 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: 18268111
• MDR Text Key: 329740077
• Report Number: 9617594-2023-01070
• Device Sequence Number: 1
• Product Code: FPA
• 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
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC33150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: CT CONTRAST, MFR UNK