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

Model Number	100/870/080CZ
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suction line is clogged.No additional information.
Additional Manufacturer Narrative
H10: device evaluation: one used decontaminated sample 007/910/880 8mm blu suctionaid sub-assy was returned for investigation without its original packaging (see photo of sample).Under visual inspection we noticed that suction tubing has tip formed end in suction connector which is causing reported occlusion.Each suction line assembly shall be inspected as per pwi-10001168 rev.105 operator quality check no.4.2: "flow test each sub-assembly, place the tapered end of the connector on to the test nozzle, and visually confirm that the top of the flow indicator is above the minimum flow requirement of 4 ltr/min @ 70 mbar pressure." testing was replicated on returned sample by manufacturing quality engineer (b)(6) (flow meter g:01874-cz).It was found that flow is occluded and do not meet minimum air flow.The customer stated problem was duplicated.The cause of the reported problem was traced to the manufacturing process.Any other similar customer complaint has not been received against smiths medical czech republic suction line production therefore this incident is considered to be isolated failure only.All operators who are working on affected workplace were informed by manufacturing quality engineer (b)(6).Further more quality alert which is describing what was happened was placed on affected workplace.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, TRACHEAL (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; bangna-trad road; minneapolis, MN 55442
• MDR Report Key: 14137977
• Report Number: 3012307300-2022-06559
• Device Sequence Number: 14459308
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: 15019315104862
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 09/21/2025
• Device Model Number: 100/870/080CZ
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 4039626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• 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
• Patient Ethnicity: Non Hispanic