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

Catalog Number 21-7106-24

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fatigue (1849); Rash (2033); Complaint, Ill-Defined (2331)

Event Date 03/26/2018

Event Type  malfunction  

Event Description

Information was received indicating that this extension set exhibited leakage.The medication that was being infused leaked onto the patient's skin and resulted in a rash on the skin.The patient also noted that they felt poorly and were more fatigued with decreased energy and an increased need for oxygen.No adverse patient effects were reported.

Manufacturer Narrative

Nine samples were returned for analysis in used condition inside a plastic bag with their original open packaging.Visual inspection of the samples showed delamination in the joints of the filter with the tube.Functional testing included leak testing.Leak testing on all the samples received were performed using hydrostat vessel to look for unusual functions; a leak was observed fleeing from the air vent of the filter in seven of the samples.A review of the manufacturing process was performed in order to verify that there are no situations or practices that could cause or contribute to the field observation, no discrepancies were found.Based on the evidence, the complaint was confirmed.The root cause of the leak was attributed to either the filter being sent by the supplier in defective conditions or the filter becoming damaged after leaving the manufacturer.

• Brand Name: CADD® CADD® EXTENSION SETS
• 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: 7519949
• MDR Text Key: 108493244
• Report Number: 3012307300-2018-01769
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/07/2022
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 57X503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1