MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ INTRAVENOUS FILTER; FILTER, INFUSION LINE

Catalog Number MX1484CZ

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2017

Event Type  malfunction  

Manufacturer Narrative

The reporter provided a catalog number of mx1484, however, the correct catalog number for the reported is lot is mx1484cz.The manufacture date provided by the reporter is october 19th 2016, however, the correct manufacture date for the reported lot is october 21st 2016.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that upon cleaning a medex¿ intravenous filter prior to the administration of antibiotics, the filter "snapped in two".No injury was reported.

• Brand Name: MEDEX¿ INTRAVENOUS FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC A. S.; olomoucká 306; hranice 1 - mesto; hranice, 753 0 1; EZ 753 01
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6605924
• MDR Text Key: 76504935
• Report Number: 3012307300-2017-01146
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/19/2021
• Device Catalogue Number: MX1484CZ
• Device Lot Number: 3305246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1