MAUDE Adverse Event Report: ICU MEDICAL, INC. 117" BURETTE SET

Model Number B3000-76

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

A review of lot# 3114117 showed (b)(4) each were manufactured, tested, inspected and released in (b)(6) 2015 with no anomalies cited.Not returned.

Event Description

Complaint received regarding several b3000-76, 117" 60 drop 150ml burette set, rotating luer, lot# 3114117 (mfg'd 10/2015).Report states, "when used in pediatrics for anesthesia (not through a pump), the auto shut off does not shut efficiently and allows for air to get into the tubing.Because this is in pediatrics the hospital views the air in the tubing as dangerous and cannot use the set as designed." no serious/adverse patient consequences reported.

• Brand Name: 117" BURETTE SET
• Type of Device: 117" BURETTE SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 5329847
• MDR Text Key: 34488854
• Report Number: 2025816-2015-00146
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: B3000-76
• Device Catalogue Number: B3000-76
• Device Lot Number: 3114117
• Is the Reporter a Health Professional?: Yes
• 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