MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION 72" LINE WITH 0.2 FILTER; FILTER, INFUSION LINE

Catalog Number UNKNOWN

Device Problems Crack (1135); Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem Underdose (2542)

Event Date 02/09/2014

Event Type  malfunction  

Event Description

A 0.2 micro filter on iv tubing appeared to be cracked at the filter.It was found to be leaking normal saline flush and blood was backed up into tubing.There was a hydrocortisone iv medication infusion prior to flush - it is not clear if full medicine amount was received by patient.The physician was notified and no new orders received.

• Brand Name: MEDFUSION 72" LINE WITH 0.2 FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier-rings road; dublin OH 43016
• MDR Report Key: 3652696
• MDR Text Key: 16058239
• Report Number: 3652696
• Device Sequence Number: 1
• Product Code: FPB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2014
• Patient Sequence Number: 1
• Patient Age: 8 DAY
• Patient Weight: 3