MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX CAPS CONNECTORS ADAPTERS AND LUERS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX7624
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The sample exhibited damage and detachment of the component.The problem source could not be identified.Dhr review was done, no issues related to the original complaint were found.
Event or Problem Description
It was reported that the connection broke and nurse had to replace it.

• Brand Name: MEDEX CAPS CONNECTORS ADAPTERS AND LUERS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; suite 750; minneapolis, MN 55442
• MDR Report Key: 13542275
• Report Number: 3012307300-2022-03461
• Device Sequence Number: 4360022
• Product Code: FPA
• UDI-Device Identifier: 10351688505309
• UDI-Public: 10351688505309
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: MX7624
• Device Catalogue Number: MX7624
• Device Lot Number: 4029335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown