MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUE LINE ULTRA SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/856/080
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received that a smiths medical portex blue line tracheostomy tube inner cannula was found to be the wrong size, the size 8.0 inner cannula contained the 9.0 size instead.The problem was discovered in use, while attempting to fit the product with a patient's tracheostomy (trach) tube.To resolve the issue, the patient's nurse was able to use another inner cannula from the same lot that was the correct size.No adverse patient effects were reported.
Additional Manufacturer Narrative
This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.G5 510k is unknown.No information has been provided to date.A review of the device history records showed there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.The returned sample consists of one cannula, the returned sample was received in used conditions without its original packaging.Visual inspection was performed at a distance of 12 to 16 inches and normal conditions of illumination and it was observed that the part number indicates an 8.0 mm inner cannula and the cannula packaged was a 9.0 mm inner cannula.The root cause is due to manufacturing.Retraining to the production personnel was conducted by quality engineer.Updated g1 contact name updated h3 device evaluated by manufacturer updated h6 event problem and evaluation codes updated h10 additional manufacturer narrative.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; boundary road, hythe; kent ct21 6jl; kent, ; UK
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8087487
• Report Number: 3012307300-2018-08446
• Device Sequence Number: 1587622
• Product Code: BTO
• UDI-Device Identifier: 55019315052628
• UDI-Public: 55019315052628
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K030381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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 Expiration Date: 02/08/2023
• Device Model Number: 100/856/080
• Device Catalogue Number: 100/856/080
• Device Lot Number: 3578884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• 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