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

Catalog Number 100/550/000

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Products was not packed, sealed packaging is empty.Instead of 2pcs inside the box, there was only 1pc and 1 empty packaging.No patient involvement.

Manufacturer Narrative

Other, other text: one (1) shelf box with instructions for use (ifu) and an empty pouch of lot code 100/550/000 lot 4097683 was received for investigation.Visual inspection was performed to returned device.Device analysis results: complaint is confirmed as the returned sample (b)(6) p/n 100550/00) was found empty.During investigation packaging line was audited on 26/apr/22 while lot 4277837, part number 100/550/000 was being packed, it was observed that workstation has a weight scale which is tare as per the manufacturing procedure va-10008113 rev- 101 visual aid to tare the weighing machine of d's and thermovent products.During meeting with operators, it was reported that machine cycle is too high, and packaging workstation gets overloaded when code 100/550/00 is running.It was observed that there is not balance sheet for this part number.It was observed that machine cycles are not recorded nor verified during machine start up.The cause was determined to be work overloading in packaging workstation due to lack of balance sheet for code 100/550/000.The action taken was reinforcing weight scale tare according to va-10008113 for all operators in packaging station.This was completed on 03-may-2022.A manufacturing dhr review was performed for lot 4097683 from pn: 100/550/000.It was manufactured on smiths medical mmon site on 15/jan/2021 per 2,800 pieces.No discrepancies were observed during the manufacturing of this lot.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

• Brand Name: PORTEX ORATOR TRACHEOSTOMY SPEAKING VALVE
• 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; minneapolis, MN 55442
• MDR Report Key: 14186740
• MDR Text Key: 289874295
• Report Number: 3012307300-2022-06852
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 06/14/2022

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
• Device Catalogue Number: 100/550/000
• Device Lot Number: 4097683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1