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

Model Number 21-7106-24

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fatigue (1849); Headache (1880)

Event Date 03/04/2019

Event Type  malfunction  

Event Description

Information was received that during use of this smiths medical cadd extension sets, leak at the connection and height of the filter was noticed.It was reported that the leakage was discovered in the morning because nightwear was wet.Subsequently, the patient switched to a new line.Reported that the patient experienced headache and fatigue.No additional adverse effects were reported.

Manufacturer Narrative

Returned device was received in good physical condition.During the evaluation of the device there was delamination found in one of the joins of the filter with the tube.Leak testing was performed and a leak was observed feeling from the air vent of the filter in the sample.No discrepancies were found in nine samples in unused conditions.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.

• Brand Name: CADD EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9153269
• MDR Text Key: 161813640
• Report Number: 3012307300-2019-05533
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/04/2023
• Device Model Number: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 58X048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1