MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX ADD-ON KIDS KIT 19 INCH CLOSED BLOOD SAMPLE KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number MX4133

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the "cx" was trying to draw into the syringe from the access port, but it would only draw up air.Adverse effects have not been reported to date.

Manufacturer Narrative

B3: date of event and d5: operator of device are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

H3 and h6 - updated.One device was received for investigation.The device was visually inspected and functionally tested.The reported complaint could not be confirmed since the returned sample was found within specifications and water was observed to flow accordingly.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: MEDEX ADD-ON KIDS KIT 19 INCH CLOSED BLOOD SAMPLE KIT
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 9124 polk ln, suite 101; olive branch MS 38654
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18751691
• MDR Text Key: 335902232
• Report Number: 3008818980-2024-00006
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MX4133
• Device Lot Number: 4411239
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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