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 Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Information was received indicating that this extension set exhibited leakage.Due to the leakage, the patient was hospitalized and began taking additional medication.No additional adverse patient effects were reported.

• 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: 7538461
• MDR Text Key: 109061837
• Report Number: 3012307300-2018-02111
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 58X042
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Outcome(s): Hospitalization