MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOTRACHEAL TUBES SILICONIZED; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/166/070J

Device Problem Disconnection (1171)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the inflation line got detached from the tube.No patient injury.No additional information is available for this complaint.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).Additional information: manufacturer name added.No problem or issues were identified during the device history record review.Five photos were attached in agile attachments for evaluation.Inflation line was broken, and a bite was observed; the complaint was confirmed.One sample was also returned for evaluation; the sample was received in used condition without original packaging.The returned sample was visually inspected under normal conditions of illumination.The inflation line was detached from tube, complaint was confirmed.One sample in the inventory was taken in attempt to replicate the failure mode, pulling the tube to see if it can be broken in half.It was not possible replicate the failure mode, the inflation line cannot be broken in half and the damage on tube is not similar compared to the sample returned.Production personnel performs a 100 percent visual inspection to inspect for the following: damage to parts (including scratches), distortion /warped; parts are verified for assembly, correct components, features, elements and/or shape.Based on the analysis conducted in the photo provided, the most probable root cause is that tube was broken off by the end user since a bite mark was noticed on the tube per photo received.No action taken required since the failure mode reported is not attributable to the manufacturing process.

• Brand Name: PORTEX ENDOTRACHEAL TUBES SILICONIZED
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 14631668
• MDR Text Key: 293539148
• Report Number: 3012307300-2022-11089
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/166/070J
• Device Lot Number: 4153147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1