MAUDE Adverse Event Report: ICU MEDICAL, INC. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number MC9079

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

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

Event Date 11/20/2020

Event Type  No Answer Provided  

Event Description

Patient with a single lumen picc line was found to have air in line a total of 5 times during the 12 hour shift, and was found to have blood backed up in line for a total of 2 times.Both the air and the blood were able to be cleared from the line without the need to open the line to the patient.

• Brand Name: 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, 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: 11064543
• MDR Text Key: 223385630
• Report Number: 11064543
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MC9079
• Device Lot Number: 4915987
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11 DA