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

Model Number 101/860/080CZ

Device Problem Connection Problem (2900)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Device serial number/lot number is unknown, no product information has been provided to date.A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that during the use of the product, the customer noticed that the suction line connector was attached in an opposite direction, which did not allow the customer to connect the connector to the mating component or perform a suction properly.No patient injury reported.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.One decontaminated sample was returned for investigation.Under visual inspection we noticed that suction connector was bonded with the tube suctionaid in opposite direction as reported by customer.The customer reported issue was confirmed.Affected part suction line sub-assembly is manually assembled.History of customer complaints and internal nonconformities (ncmrs) was reviewed and any similar nonconformity was recorded.This incident is therefore considered to be isolated incident only caused by sister site operator error.The cause of the reported problem was traced to the supplier manufacturing process.No lot number was provided; therefore, dhr (device history review) could not be performed.

• Brand Name: PORTEX TUBES BLUSELECT
• 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): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima; minneapolis, MN 55442
• MDR Report Key: 15914514
• MDR Text Key: 307593964
• Report Number: 3012307300-2022-27738
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 55019517076156
• UDI-Public: 15019517076158
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• 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,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1