MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; ENDROTRACHEAL

Model Number	197-39R
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex endobronchial tubes malfunctioned.It was reported the tube was unpacked from sterile packaging and the cuff tested for leakage.The mandrin was then removed for lubrication, when the customer noted that the mandrin glides very slowly ,both before and after applied lubricant.Then the tube was more thoroughly examined it was then discovered a clamping distal to the tracheal cuff.The tube was therefore not attempted used and a new one was retrieved.Pictures were attached.No patient involvement or adverse events reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.Two photos were received for evaluation.Incorrect forming of the tube was observed; the complaint was confirmed.The root cause of the reported issue could be cause by not following properly the checking of the tube width forming fixtures.Actions were taken to mitigate the reported issue: a quality alert was generated to production personnel to explain the importance to adherence or following in the procedure.

• Brand Name: PORTEX
• Common Device Name: ENDROTRACHEAL
• 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; minneapolis, MN 55442
• MDR Report Key: 11852638
• Report Number: 3012307300-2021-04675
• Device Sequence Number: 3149353
• Product Code: CBI
• UDI-Device Identifier: 15019315058578
• UDI-Public: 15019315058578
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K953483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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 Expiration Date: 06/05/2021
• Device Model Number: 197-39R
• Device Catalogue Number: 197-39R
• Device Lot Number: 3636969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown