MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. ITEM SETUP FOR SMJ - EPX729/118CJP; ANESTHESIA CONDUCTION KIT

Catalog Number EPX729/118CJP

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).One kit product was returned.The catheter, the epifuse connector, the flat filter were connected and the cover was attached.Water was injected into the connected components with a syringe, liquid leakage from each component was not observed.Observation of each component confirmed that the catheter was inserted all the way into the sleeve and that there was no problem with the connection between the catheter and the epifuse connector.No abnormality such as breakage or leakage was found.The reported event was not confirmed.

Event Description

It was reported that leakage occurred in the middle of the catheter during use to the patient.No adverse events.

• Brand Name: ITEM SETUP FOR SMJ - EPX729/118CJP
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL JAPAN LTD., KOMAKI; 627-1 yokouchi; komaki-shi, aichi 485-0 081; JA 485-0081
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7651235
• MDR Text Key: 112774506
• Report Number: 3012307300-2018-02521
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: EPX729/118CJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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