MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	101/573/000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received for investigation one decontaminated single stage dilator with guiding catheter.No original packaging was included.Visual inspection of the sample received showed that a portion of the guiding catheter had broken off and was loose in the bag.They were yellowish in color.When examining the dilator, more fragments broke off, thus complaint confirmation.The procedural tray is assembled by hand and pictures are taken of the assembled kits.A device history record (dhr) review shows the dilator and guiding catheter were intact.Although the complaint was confirmed, it is not clear how the breakage occurred.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.
Event or Problem Description
It was reported that while inserting the guide stylet through the dilatator, pieces of the guide broke off.The event occurred immediately on use.There was patient involvement, and no patient harm/adverse event reported.

• Brand Name: BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21028527
• Report Number: 1217052-2024-00283
• Device Sequence Number: 14508915
• Product Code: JOH
• UDI-Device Identifier: 15019517103434
• UDI-Public: (01)15019517103434(17)250901(10)6003279
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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 Expiration Date: 09/01/2025
• Device Catalogue Number: 101/573/000
• Device Lot Number: 6003279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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