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

Model Number 100/870/080CZ

Device Problem Connection Problem (2900)

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

Event Date 03/11/2022

Event Type  Injury  

Event Description

It was reported that the inner cannula cannot lock in the tracheostomy tube.

Manufacturer Narrative

Customer reported item 100/870/080cz lot 4121481 received at mmuc item 100/810/085cz lot 3725972.Customer not able to verify.Device evaluation: one original shelf carton 100/810/085cz lot 3725972 including one not opened unit pack was received for investigation (see photo of sample).Unit pack was opened and it was found that inside 8.5mm kit 100/810/085cz lot 325972 there is incorrect size tracheostomy tube.There was 007/910/675 but there should be 007/910/685.Furthermore incorrectly printed patient label 003/433/002 was found inside blister.Patient label was printed as 100/810/075cz lot 3717992 but it should be printed as 100/810/085cz lot 3725972.Based on this visual inspection component mixup was confirmed.Product size mixup resulted to reported problem - 8.5mm inner cannula cannot be inserted into 7.5mm tracheostomy tube.Any other customer complaint which is describing the same issue with 100/810/085cz lot 3725972 nor 100/810/075cz lot 3717992 was received.Due to fact that incorrect components were found inside sealed unit pack this issue is considered to be manufacturing error.Complaint was escalated to ncr-001249 where further investigation and assessment will be documented.Following dhr review was performed: finish good work order 100/810/085cz lot 3725972, manufacturing date 2018-11-05, quantity 416pcs.During manufacturing of this batch ncmr1656 was raised due to inner cannula contamination.Whole work order was 100% reinspected and non-conforming pieces were reworked (re-packed).There is no record within dhr which indicates that mixup might happen during manufacturing.Finish good work order 100/810/075cz lot 3717992, manufacturing date 2018-11-06, quantity 911pcs.During manufacturing of this batch ncmr1652 was raised due to loose particle in finish good kit.Whole work order was 100% reinspected and non-conforming pieces were scrapped.There is no record within dhr which indicates that mixup might happen during manufacturing.Based on dhr records those two work orders were packed the same day 09-nov-2018 on packaging machine ulma.The same day blisters which were rejected during packaging were repackaged (re-do process).It is the most probable that mixup happened 09-nov-2018 during packaging process or during re-do process.Based on dhr records line clearance (czhdp4008) was performed on those two work orders by the same operator - (b)(4).Packaging of those two work orders was done also by the same operators - (b)(4).Customer also mentioned product 100/870/080cz lot 4121481 but this products does not seem to be related to this customer complaint - its packaging was done in different time period (may 2021) and anything related to 8.0mm size was received.

Manufacturer Narrative

H1 corrected from malfunction to serious injury reportable.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID
• Type of Device: 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: 14137852
• MDR Text Key: 289465042
• Report Number: 3012307300-2022-06557
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: 15019315104862
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K030570
• 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,Followup
• Report Date: 11/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 100/870/080CZ
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 3725972
• Was Device Available for Evaluation?: No
• 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: 04/18/2022
• Supplement Dates Manufacturer Received: 05/12/2022; 10/30/2023
• Supplement Dates FDA Received: 06/02/2022; 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic