MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX CONTINUOUS CAUDAL /PEDIATRIC EPIDURAL TRAYS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Material Fragmentation (1261)

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

Event Date 06/01/2020

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the customer noticed the silicone ring attached to the device connector got caught in the syringe, which did not allow them to perform an infusion.No patient injury was reported.

Manufacturer Narrative

No samples were returned.As a result of connecting an device connector with a silicon ring in our stock and a syringe with nrfit, it was confirmed that the silicon ring rebounded and it was difficult to connect with the syringe.The root cause is likely to be a long silicon ring, which interferes with the connection of devices other than flat filters.No lot number was provided; therefore, device history record review could not be completed.Lot # and protocol # are unknown.No product 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: PORTEX CONTINUOUS CAUDAL /PEDIATRIC EPIDURAL TRAYS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15310844
• MDR Text Key: 305154345
• Report Number: 3012307300-2022-16497
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1