MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ HEMODRAW® CLOSED BLOOD SAMPLING SYSTEM; ARTERIAL BLOOD SAMPLING KIT

Catalog Number MX9615H002C2CZ

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

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 a medex¿ hemodraw® closed blood sampling system was unable to be used due to spontaneous tube disconnection.The issue was observed prior to patient use.No patient injury was reported.See mfr: 3012307300-2017-00791.

Manufacturer Narrative

One used medex¿ hemodraw® closed blood sampling system.Upon visual observation it was verified that the product was complete and assembled according to the current drawing.The returned device was separated between the red dash tubing and the top of the reservoir.Closer observation of the tubing tip by unaided eye showed there could be traces of solvent.The device history record was reviewed and there were no nonconformities, excessive scrap level, or any other relevant issues detected.The complaint was confirmed, but no root cause was determined.

• Brand Name: MEDEX¿ HEMODRAW® CLOSED BLOOD SAMPLING SYSTEM
• Type of Device: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC A. S.; olomoucka 306; hranice 1 - mesto; hranice, 753 0 1; EZ 753 01
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6454519
• MDR Text Key: 71542945
• Report Number: 3012307300-2017-00847
• Device Sequence Number: 1
• Product Code: CBT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: MX9615H002C2CZ
• Device Lot Number: 3172379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• 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