MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES PDT BLUPERC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 101/562/000

Device Problem Component Missing (2306)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, the customer noticed no long dilator and guarding catheter came with the product set.No patient injury reported.

Manufacturer Narrative

Udi is unknown.No information has been provided to date.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Investigation of this complaint was done based on photos as it was agreed with decontamination center that no physical samples are needed for this investigation.A visual testing was performed and that the customer discovered missing needles after unit pack opening were unable to comment presence of the components in the unit pack before opening.The root cause of the reported issue was found to be that affected work order was 100 percent repacked due to labelling issue and the reported failure happened the most during this repackaging.In (b)(6) 2022 vision camera system has been successfully implemented into ultraperc packaging process therefore presence of all components within blisters is 100% verified prior blister sealing process.

• Brand Name: PORTEX TUBES PDT BLUPERC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east; minneapolis, MN 55442
• MDR Report Key: 16079952
• MDR Text Key: 306502812
• Report Number: 3012307300-2022-28339
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101/562/000
• Device Lot Number: 4245281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1