MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LOGICATH¿ CATHETER; CANNULA, CATHETER

Catalog Number MXA232X16X40J-NIT

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation was performed on a smiths medical catheter.No failure was detected when dhr was performed.No actual device was returned, however customer did provide photographs.According to the provided pictures a damage or deviation on the catheter delta cannot be determined.No picture of the suture wing and clip was provided and therefore it is unknown if the suture wing and clip was used to fix the catheter.Within the ifu for the logicath single and multiple lumen cvcs 004/009/104a there is exactly written how to fix the catheter safely.On the one hand it is described how to fix the catheter with the delta.On the other hand it's also mentioned how to fix the cvc with the help of the moveable suture wing and clip.Based on the above information it is felt that this incident is not due to a product failure of the catheter.The reported failure could not be confirmed with the provided pictures and missing sample.

Event Description

Information was received that a smiths medical central venous catheter was difficult to place.This happened during testing of the device.No patient injury resulted.

• Brand Name: LOGICATH¿ CATHETER
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; bretonischer ring 3; grasbrunn, 85630 ; GM 85630
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7679197
• MDR Text Key: 113945875
• Report Number: 3012307300-2018-02772
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MXA232X16X40J-NIT
• Device Lot Number: 3422810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Date Manufacturer Received: 06/13/2018
• 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: N
• Patient Sequence Number: 1