MAUDE Adverse Event Report: ST PAUL DELTEC; TRACHEAL TUBES

Model Number	21-3468-24
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device had resistance to flushing due to kinking.No patient injury reported.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-19212
• Device Sequence Number: 20021078
• Product Code: FPA
• UDI-Device Identifier: 10610586033070
• UDI-Public: 10610586033070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female