MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM, 19 INCH; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number MX4133

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that kids kit attachment site continued to spin rather than attach securely to the line set up.There was patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

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

Investigation codes: updated.Investigation summary: one used sample outside its original packaging was received for evaluation.It was functionally tested for water leaks and did not exhibit leakage.The syringe also filled correctly with water without drawing in any air.The sampling site was also tested by inserting component p1369-80 into the rubber pn: p1001-12.The water flowed accordingly, and no obstructions or air were observed to be drawn in the syringe used.The customer's indicated failure could not be replicated or confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM, 19 INCH
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18907235
• MDR Text Key: 337701057
• Report Number: 1526863-2024-00012
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 10351688507853
• UDI-Public: (01)10351688507853(17)260626(10)4411239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX4133
• Device Lot Number: 4411239
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• 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