MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Catalog Number MX4705

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.

Event Description

It was reported that a medex¿ clear-cuff pressure infusor had leaked.This incident was observed during testing after the infusor had been inflated and had sat overnight for around 15 hours.No patient was involved.

Manufacturer Narrative

One medex¿ clear-cuff pressure infusor was returned for investigation.A review of the device history record, relevant to the reported lot, found no issues during manufacturing.During visual and functional testing, the returned device was inflated multiple times and an air leak was found.The leak was located at the plunger end of the assembly unit.Investigation determined that the root cause of the leak was due to a manufacturing issue and was an exception in the initial manufacturing of the device.

• Brand Name: MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 6250 shier rings road,; dublin OH 43016
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6249004
• MDR Text Key: 65204731
• Report Number: 3012307300-2017-00192
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MX4705
• Device Lot Number: 2786208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• 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