MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MC33131

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without the returned device a probable cause is unable to determined.

Event Description

The event involves a 7" (18 cm) appx 0.43 ml, pressure infusion (400psig) ext set w/microclave® clear, purple clamp, rotating luer that the customer stated the hospital is having issues with prefilled syringes of naloxone made by dr.(b)(6) and auromedics.The syringe barrels appear to be very similar in design.The issue arises when the syringe is attached to the set, the small plastic tube in the extension set becomes lodged in the fluid path of the syringe and breaks off.Additionally, the customer reported the timeliness of the administrations and the loss of intravenous lines due to the broken j-loops.There was patient involvement, however, no report of harm.This captures the third of three events reported.

• Brand Name: 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR
• 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: 13265462
• MDR Text Key: 286735410
• Report Number: 9617594-2022-00005
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33131
• Device Catalogue Number: MC33131
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• 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: NALOXONE PREFILLED SYRINGE, AUROMEDICS MFR; NALOXONE PREFILLED SYRINGE, DR. (B)(6)