MAUDE Adverse Event Report: ICU MEDICAL, INC. 4" SMALLBORE EXT SET, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number B1028

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

We have had multiple extension set's leaking in the past week.The only thing i can think of is that we received a new box of these about 2 weeks ago.I have pulled all of the product off the shelves.Resulted in a baby getting another picc line.His risk of a central line infection is increased due to the unneeded line change.

• Brand Name: 4" SMALLBORE EXT SET, CLAMP, ROTATING LUER
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 12165627
• MDR Text Key: 261473827
• Report Number: 12165627
• 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: 07/09/2021

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: No Information
• Device Model Number: B1028
• Device Catalogue Number: B1028
• Device Lot Number: 5254917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 DA
• Patient Weight: 1