MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD® EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7394-24

Device Problems Incomplete or Inadequate Connection (4037); Priming Problem (4040)

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

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

Seven cadd® extension sets were returned for analysis.The samples received were visually inspected and no abnormality was found.An iso gage was used to look for unusual functions during the test and no indication of a loose connection or incorrect dimension of the component was detected.A review of the manufacturing process was performed; no discrepancies were observed.Root cause cannot be determined since the complaint was not confirmed due to the fact the samples verification was successfully passed.

Event Description

Information was received indicating that a smiths cadd® extension set becomes disconnected from the device.It was also reported that the extension set was difficult to prime.There was no reported injury to the patient.

• Brand Name: CADD® EXTENSION SET
• 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; minneaplois, MN 55442 ; 7633833310
• MDR Report Key: 8250770
• MDR Text Key: 133208130
• Report Number: 3012307300-2019-00242
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7394-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Date Manufacturer Received: 08/14/2018
• 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: Unknown
• Patient Sequence Number: 1