MAUDE Adverse Event Report: ICU MEDICAL INC. IV TUBING CUSTOM SET ; STOPCOCK, I.V, SET

Model Number B33004

Device Problems Break (1069); Defective Component (2292)

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

Event Type  malfunction  

Event Description

This is a custom set from icu medical (b33712); i have sent the defective tubing to the company for qa.Lot numbers: 4418284, 4429455, and 4174367.Ref # rma #: (b)(4), item lot product description: b33712 - 4418284 - 38" (97 cm) appx 4.9 ml, ext set w/2 clave, microclave t-connector, remv 4-way stopcock, 3 clamps, rotating luer, 1 smallbore ext, event: it breaks at the 1-port by the microclave date reported to icu medical: (b)(6) 2020.Ref #rma#: (b)(4) (this is for the 30 times that it happened with different unk lot numbers) item - lot - product description: b33712- unk - 38" (97 cm) appx 4.9 ml, ext set w2 clave, microclave t-connector, remv 4-way stopcock, 3 clamps, rotating luer, 1 smallbore ext, event: it breaks at the microclave; date reported to icu medical: (b)(6) 2020.At first glance it appears that the microclave is not bonded to the tubing on the t-connector (item (b)(4)), causing it to break.Fda safety report id# (b)(4).

• Brand Name: IV TUBING CUSTOM SET
• Type of Device: STOPCOCK, I.V, SET
• Manufacturer (Section D): ICU MEDICAL INC.
• MDR Report Key: 9727845
• MDR Text Key: 180172669
• Report Number: MW5093046
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B33004
• Device Catalogue Number: CN-055799
• Device Lot Number: 4418284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1