MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL 131" SINGLE LEAD TRANSFER SET W/CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Lot Number 5065292

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 04/09/2021

Event Type  malfunction  

Event Description

Icu medical 131" single lead transfer set 2/clamp, luer lock tubing set leaks after it is attached to iv bag.This has been observed in 6 other sets from the same lot number by the same manufacturer.Fda safety report id# (b)(4).

• Brand Name: ICU MEDICAL 131" SINGLE LEAD TRANSFER SET W/CLAMP, LUER LOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC. ; san clemente CA 92673
• MDR Report Key: 11655418
• MDR Text Key: 245391489
• Report Number: MW5100727
• Device Sequence Number: 1
• Product Code: FMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/09/2021
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 5065292
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1