MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® MEDICATION CASSETTE RESERVOIR; PUMP, INFUSION

Catalog Number 21-7002-24

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Patient reported her medication cassette detached from the extension set tubing and needed tape to keep the ends together.No patient injury was associated with this incident.

• Brand Name: CADD® MEDICATION CASSETTE RESERVOIR
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7593119
• MDR Text Key: 110848345
• Report Number: 3012307300-2018-02258
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586022128
• UDI-Public: 10610586022128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K843772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

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: Lay User/Patient
• Device Expiration Date: 09/27/2022
• Device Catalogue Number: 21-7002-24
• Device Lot Number: 17X650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2017
• 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
• Patient Weight: 54