MAUDE Adverse Event Report: ICU MEDICAL, INC. 4¿ SMALLBORE EXTENSION SET WITH 1.2 MICRON FILTER; STOPCOCK, I.V. SET

Model Number B1755

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Physical Property Issue (3008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

Registered nurse was priming the smallbore extension set with 1.2 micron filter with lipids when she noticed that the arrow printed on the filter was pointing the wrong direction.Upon further inspection, it was found that the arrow was printing incorrectly on the filter.

• Brand Name: 4¿ SMALLBORE EXTENSION SET WITH 1.2 MICRON FILTER
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 7098967
• MDR Text Key: 94208223
• Report Number: 7098967
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2017

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: Nurse
• Device Model Number: B1755
• Device Catalogue Number: B1755
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 2