MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MICRON FILTER; FILTER, INFUSION LINE

Lot Number 3899558

Device Problem Disconnection (1171)

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

Event Date 02/22/2020

Event Type  malfunction  

Event Description

Two rn's & 1:1 sitter at bedside during the time of this event.Patient was being supervised very closely at this time while changing diaper and bedding.Patient was sitting up and did not touch line at this time, was very cooperative.Line became disconnected on its own and was found lying on the bed after completion of cleaning patient.

• Brand Name: MICRON FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9834778
• MDR Text Key: 183520321
• Report Number: 9834778
• Device Sequence Number: 1
• Product Code: FPB
• 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: 03/05/2020,02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 3899558
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3285 DA