MAUDE Adverse Event Report: ICU MEDICAL, INC. SMALLBORE SET NANOCLAVE MANIFOLD; STOPCOCK, I.V. SET

Catalog Number AM6130

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2021

Event Type  malfunction  

Event Description

Patient had gtt (drops) line changed at evening.Midnight, rn noticed small wet spot on linens.Touched all connections of the 6-piece gang and felt wetness on a part of the gang that we don't connect when building the line.Line found to be leaking.New line set up build and switched over.Discontinued cracked set up of gtts (drops).Crack in gang, leaking medication.Gang was bagged and put in charge office.

• Brand Name: SMALLBORE SET NANOCLAVE MANIFOLD
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11378502
• MDR Text Key: 241235901
• Report Number: 11378502
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AM6130
• Device Lot Number: 485000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 180 DA
• Patient Weight: 5