MAUDE Adverse Event Report: ICU MEDICAL, INC. MICROCLAVE CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Material Fragmentation (1261); Obstruction of Flow (2423)

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

Event Date 01/26/2021

Event Type  malfunction  

Event Description

It was discovered at our hospital recently that nurses are having issues with pushing naloxone syringe via iv when we switched to dr.(b)(6) (due to a backorder of our regular manufacturer).Upon our medication safety team's investigation (using new materials), we found the naloxone syringe is being clogged by a piece of the silicone seal from microclave connector.Such is not experienced by ns flushes.It appears that there are other scenarios which would cause the syringe to not work which we have no idea of.We had a different set of dr reddy's syringe (same lot) connected to j-loop.The syringe is not able to be pushed through the line even though a ns flush can.No visible clog is observed.The point of failure is discovered to be where the naloxone syringe nozzle connects with the microclave.The nozzle is so small such that it 'pinches' the silicone seal, causing it to fragment, and clog the nozzle/microclave, rendering it useless (and possibly harmful by forcing the cored material into patient).We have tested and recreated the failure with just the microclave connector, but the patient was actually having the j-loop that already came with the microclave connector.Please note this is just one of the scenario where we were able to recreate the failure repeatedly.There may be other combinations (different lines, adapters) where the naloxone syringe have known to fail which we were not involve in.We contacted the manufacturer via on 1/26/21 with no response despite a follow up email.Fda safety report id# (b)(4).

• Brand Name: MICROCLAVE CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 11422184
• MDR Text Key: 238645615
• Report Number: MW5099816
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/03/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2021
• Patient Sequence Number: 1