MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC DELTEC LOGICATH CONVENTIONAL - NEO/PED; CANNULA, CATHETER

Catalog Number MXA232X16X40J-NIT

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned by the customer due to contamination.Also no picture was provided.Therefore a complete investigation was not possible.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Event Description

It was reported that that during the infusion of solutions into one of the catheter pathways, reflux was observed on the other route.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Device evaluation: cadd administration sets was returned for analysis.The samples were visually inspected at a distance of 12" to 24" under normal conditions of illumination.Delamination was found at least in one join of the filter with the tube in both samples received.Leak testing on the samples received were performed using hydrostat vessel to look for unusual functions.No leaks were detected from the delamination joins nor other solvent bonds, or the air vent in any of the sample received.The customer's reported problem could not be duplicated.The reported issue root cause cannot be determined since the complaint was not confirmed due to the fact the leak test was successfully passed.No corrective actions are required since the complaint was not confirmed.However, production personnel were notified by quality engineer as awareness of the defect reported by the customer.

• Brand Name: DELTEC LOGICATH CONVENTIONAL - NEO/PED
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8609058
• MDR Text Key: 145012997
• Report Number: 3012307300-2019-02553
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: MXA232X16X40J-NIT
• Device Lot Number: 3468082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1