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

Model Number	100/870/080CZ
Medical Device Problem Codes	Crack (1135); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported there is a visible split in the cuff's suction port while using a luer lock syringe.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: the device was returned for investigation.One used decontaminated sample 007/910/880 8mm blu suctionaid sub-assy with a terumo brand syringe (not part of finish good kit 100/870/080cz) were received.Under visual inspection suction connector seems to be without any defect.Then a syringe was inserted into the connector and crack in connector split line was observed.Inspection process which is able to detect such damage is in place.During manufacturing process which is described in pwi-10003123 rev.102 suction connectors are periodically inspected (1pcs from each cavity when production starts and then every 4 hours and after any machine stoppage).Part of inspection is functional test by the help of 6% luer taper gauge with weight 500g.History of mczh ncmrs was checked and there was found no problem related to suction connector splitting.Occurrence of this defect is very low (this is the third complaint against (b)(4) production, previous complaints (b)(4).Root cause of this defect is currently unknown - it could be a moulding defect or excessive force used when connector was connected with syringe.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14345756
• Report Number: 3012307300-2022-08332
• Device Sequence Number: 5270130
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: 15019315104862
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/07/2026
• Device Model Number: 100/870/080CZ
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 4121481
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 06/15/2023
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/24/2022; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown