MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX T-CONNECTOR EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MX453SL

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is 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.

Event Description

It was reported, that there was an unspecified quality issue with the threaded portion of the swivel t connector.When attached to a very "large" needle already in place, in the patients back.No adverse effects reported.

Manufacturer Narrative

Evaluation codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: MEDEX T-CONNECTOR EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16915195
• MDR Text Key: 315095738
• Report Number: 3012307300-2023-05603
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10351688507174
• UDI-Public: 10351688507174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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: Other
• Device Model Number: MX453SL
• Device Catalogue Number: MX453SL
• Device Lot Number: 4270053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1