MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS WITH FLOW STOP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7394-24

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received that the cadd® administration sets with flow stop free product was occluded and caused the pump to alarm.No reported adverse effects.

Manufacturer Narrative

Correction: please retract mfr # 3012307300-2018-01716 as new information was received from the customer stating "i would like to rescind on this complaint.It was a user error, not faulty administration set".

• Brand Name: CADD ADMINISTRATION SETS WITH FLOW STOP FREE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7523136
• MDR Text Key: 108564480
• Report Number: 3012307300-2018-01716
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

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: No Information
• Device Expiration Date: 08/09/2020
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 47X528
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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