MAUDE Adverse Event Report: ICU MEDICAL MICROCLAVE; ADMIN SET

Model Number MC33098

Device Problem Connection Problem (2900)

Patient Problem Chemical Exposure (2570)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned.No additional information was provided by the initial reporter.A two year review of complaints database revealed no additional reports for mc33098/similar problem.

Event Description

Rotating luers very easily popped off any ambulatory patients.Caused chemo spill, blood spills, tpn spills and other medication and drug spills.Unprotected chemo exposure was reported.

Manufacturer Narrative

Device not returned.No additional information was provided by the initial reporter.A two year review of complaints database revealed no additional reports for mc33098/similar problem.

Event Description

Rotating luers very easily popped off any ambulatory patients.Caused chemo spill, blood spills, tpn spills and other medication and drug spills.Unprotected chemo exposure was reported.The actual devices were not returned.The exact cause of the events and disconnects remain unknown.Although there was an unscheduled device change out there was no critical delay in therapy, no change in patient's baseline clinical condition and no emergent medical treatments or interventions.

• Brand Name: MICROCLAVE
• Type of Device: ADMIN SET
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• Manufacturer (Section G): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• Manufacturer Contact: holly imes ; 4455 atherton drive; salt lake city, UT 84117 ; 8012641747
• MDR Report Key: 6796073
• MDR Text Key: 83312272
• Report Number: 2025816-2017-00193
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709037366
• UDI-Public: 887709037366
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33098
• Device Catalogue Number: MC33098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1