MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number MX9633CZ

Device Problem Leak/Splash (1354)

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

Event Date 09/29/2020

Event Type  malfunction  

Event Description

It was reported that the device was leaking and a small crack was observed in the plastic.No patient injury was reported.

Manufacturer Narrative

The visual inspection of the used sample shows many small cracks on the joint of 3-way stopcock and logical dome.Leak test was done and no leakage observed in the 3-way stopcock and logical dome connection.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; kilmarnock road; minneapolis, MN 55442
• MDR Report Key: 15397875
• MDR Text Key: 306072686
• Report Number: 3012307300-2022-18561
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX9633CZ
• Device Lot Number: 3886502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Race: White