MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SET, ADMIN, CADD, 108", SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7394-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem Underdose (2542)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical administration set was implicated in a leaking issue with a smiths medical pump.During administration of blinatumomab, the patient notified the nurse that his clothes had some wet spots periodically on them during the infusion.There were no adverse events reported due to this event.

• Brand Name: SET, ADMIN, CADD, 108", SPIKE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn ; 3833310
• MDR Report Key: 9869663
• MDR Text Key: 184632003
• Report Number: 3012307300-2020-02176
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/09/2023
• Device Model Number: 21-7394-24
• Device Lot Number: 48X091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 96