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

Model Number MC33150

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history review could not be completed due to the unknown lot number.

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 a patient had an allergy to silicone on an unknown date.The patient used a steroid cream for a raised red rash where the tubing was against the skin.There was patient involvement and patient allergy, but no patient harm was reported.

Manufacturer Narrative

The device has been discarded and is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.D9 selection.

Event Description

The customer provided additional information regarding the incident on 15-feb-2023.The patient was self-administering and removing her own peripheral intravenous (piv) lines in the home.Additionally, it was stated that the device was an extension set and remains attached to the patient¿s piv catheter.The medications involved were intermittent infusions of dextrose 5% 1/4 normal saline and ondansetron.It was also stated that the tubing was replaced and therapy was resumed.The patient tried to create a barrier between the skin and the tubing with gauze; however, the patient continued to have issues.Eventually, the doctor's office requested they put a tegaderm dressing on the skin so the extension set wouldn¿t touch it.The patient was treated with a steroid injection and topical for raised red rash.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16323218
• MDR Text Key: 309043730
• Report Number: 9617594-2023-00067
• 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,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33150
• Device Catalogue Number: MC33150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: DEXTROSE 5% 1/4 NS, UNK MFR; ONDANSETRON, UNK MFR