MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PVC - PORTEX TUBES BLUSELECT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number 100/870/080CZ

Device Problem Leak/Splash (1354)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, leakage of air from the cuff was observed.So the customer checked the product and the pilot balloon was found detached.No patient injury.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.Visual and functional tests were performed.One used decontaminated sample was returned for investigation without its original packaging.Under visual inspection we noticed that the inflation line was detached from the pilot balloon.Similar customer complaints have been recently received therefore an internal non-conformity report (ncr) was created with the purpose of evaluating this issue.The product sample was sent to the supplier for further investigation.Secondary supplier evaluation reported: the returned sample was visually inspected at 12 to 16 inches and normal conditions of illumination according to site visual inspection.Inflation line detached from pilot balloon was observed and a lack of solvent was detected; thus, the failure mode reported is confirmed.The analysis performed in the sample received concluded that the occurrence of this failure condition could be caused by: not enough thf solvent at joint cause by bad condition on the thf feeder system equipment.Action taken: to expand this investigation an ncr was opened, as were implemented immediate actions to mitigate this reported condition by improving process steps directly related with factors in process that may infer on this failure: -the checklist "inflation line subassembly", that is used to release the equipment, will include a verification in the critical alignment tooling that technician needs to do, with the purpose to confirm that tube can be inserted properly and the connection with the balloon is secure, avoiding weak join between these two components.-update checklist related used to record preventive maintenance to include a new method of the maintenance execution verification to assurance the adherence of the procedure and that samples produced after maintenance keep the quality features consistently and stably., corrected data: correction d1 - brand name.

• Brand Name: PVC - PORTEX TUBES BLUSELECT
• 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: david halverson ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 13056162
• MDR Text Key: 282620960
• Report Number: 3012307300-2021-13116
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: 15019315104862
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/870/080CZ
• Device Catalogue Number: 100/870/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1