MAUDE Adverse Event Report: ST PAUL DELTEC; TRACHEAL TUBES

Model Number 21-3468-24

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 04/01/2020

Event Type  malfunction  

Event Description

It was reported the device had resistance to flushing due to kinking.No patient injury reported.

Manufacturer Narrative

It was noted sample received: the sample consist of one (1) product returned from the customer and one (1) syringe.The sample was received in used conditions without its original packaging.Visual inspection: the sample was visually inspected at a distance of 12" under normal lighting in order to detect any damage on the unit.No discrepancies detected in the sample.Functional testing: the sample was tested with a syringe to replicate the failure mode.Occlusion was detected in the sample, in the bond between the tube and the base during the testing.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.510 number is 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: DELTEC
• Type of Device: TRACHEAL TUBES
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15422934
• MDR Text Key: 305539578
• Report Number: 3012307300-2022-19212
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586033070
• UDI-Public: 10610586033070
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-3468-24
• Device Catalogue Number: 21-3468-24
• Device Lot Number: 3938298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female