MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ULTRAPERC DILATOR KIT; DILATOR, TRACHEAL

Catalog Number	101/563/080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the product was indwelled, the inflation line got detached.No patient injury was reported.No additional information is available for this complaint.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.It was determined that it was a supplied items fault.Dhr review was done, no issues related to the original complaint were found.
Additional Manufacturer Narrative
Other text: g3: japan.Device evaluation: one device was returned for analysis in used condition.Sample was received used and decontaminated.Visual inspection showed the line was detached from the pilot balloon.The returned device had lot number 4064204 laser printed on its flange.A device history record showed that there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product., corrected data: updated: d3, d4 udi, g2.H6 patient code only 4582, update evaluation codes: result and conclusion.H10 corrected device analysis, country provided.

• Brand Name: PORTEX ULTRAPERC DILATOR KIT
• Common Device Name: DILATOR, TRACHEAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 13552687
• Report Number: 3012307300-2022-03594
• Device Sequence Number: 4372767
• Product Code: KCG
• UDI-Device Identifier: 55019517103418
• UDI-Public: 55019517103418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2022

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 Catalogue Number: 101/563/080
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 10/18/2022; 10/18/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/25/2022; 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown