MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. MEDEX EXTENSION SETS MULTI LINE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MX618

Device Problem Blocked Connection (2888)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2022

Event Type  malfunction  

Event Description

It was reported that the device was blocked.Reported lot number was 430691, but this number could not be verified.Patient involvement is unknown.

Manufacturer Narrative

Other text: d4: lot number, expiration date, udi section, g5: 510k and h4: manufacture date are unknown, no information has been provided to date.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: MEDEX EXTENSION SETS MULTI LINE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18015035
• MDR Text Key: 326645617
• Report Number: 3012307300-2023-09940
• Device Sequence Number: 1
• Product Code: OJA
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MX618
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1