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

Model Number 21-7364-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

Information was received that during use of this smiths cadd administration sets, the set tube was found leaking leaked on a normal saline hydration bag.It was reported that the tubing set was discharge.No patient adverse events reported.

Manufacturer Narrative

Other, other text: h3: one cadd administration set from part number 21-7364-24 was received in decontaminated condition inside a plastic bag with its original sealed packaging.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.No damages nor workmanship defects were found.The sample returned was tested using an hydrostatic vessel.No leaks were found fleeing from any of the joins, thus the reported leaking issue was unable to be confirmed.There was no fault found with the returned sample.

• Brand Name: CADD ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11106070
• MDR Text Key: 224741407
• Report Number: 3012307300-2021-00024
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191776
• UDI-Public: 15019517191776
• Combination Product (y/n): N
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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: No Information
• Device Model Number: 21-7364-24
• Device Catalogue Number: 21-7364-24
• Device Lot Number: 3971593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 01/03/2021
• Supplement Dates Manufacturer Received: 02/07/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1