MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX KITS OTHER; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number NSE4000CJP

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the catheter tip got torn off.No patient injury was reported.

Manufacturer Narrative

The device was returned to smiths medical.As a result of observing the sample, it was confirmed that the tip of the catheter was lost.It is probable that the catheter was cut around 8 cm from the tip of the catheter.The cut surface resembled a trace cut with scissors.It is highly probable that the catheter was damaged due to contact with scissors during use.Dhr: no lot number provided for dhr.

Manufacturer Narrative

Additional information: h6, h10.This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.A sample was received for evaluation.As a result of observing the sample, it was confirmed that the tip of the catheter was lost.From the depth marker, it is probable that the catheter was cut around 8 cm from the tip of the catheter.The cut surface resembled a trace cut with scissors or the like.No elongation could be confirmed.However, the reported event was confirmed.From the above results, it is highly probable that the catheter was damaged due to contact with scissors during use.We will report the occurrence of this event to overseas manufacturers and record this event in a database to monitor the future occurrence status., corrected data: d1, h5.

• Brand Name: PORTEX KITS OTHER
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 13536830
• MDR Text Key: 285713605
• Report Number: 3012307300-2022-03424
• Device Sequence Number: 1
• Product Code: CAI
• 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,Followup
• Report Date: 05/03/2023

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: Health Professional
• Device Catalogue Number: NSE4000CJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/02/2023
• 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