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

Model Number	100/870/085CZ
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the complaint was limited because no sample was returned.Customer provided video which is showing 007/910/885 8.5mm blu suctionaid sub-assy which is submerged in water and which is inflation tested.Air leak from cuff is evident.During manufacturing process the devices are 100 percent inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.Each cuff shall be also tested by customer prior use as per instruction for use as10001029-003 rev.100, page 4, instruction for use section, point 1: "the integrity of the cuff and inflation system should be checked prior to insertion".Customer did not define when the leak was discovered (prior use by pre-testing or during use) so we are not able to determine root cause of this incident.Majority of cuff leak related customer complaints happen during use due to contact with sharp edge which is in conflict with instruction for use as10001029-003 rev.100, page 4, precautions section, point 6 "guard against cuff damage by avoiding contact with sharp edges".Unfortunately without the sample nor information when the incident happen we are unable to determine true root cause of this issue.No trend of confirmed complaints in relation with this issue was identified.The following dhr review was performed: finish good work order (b)(4) lot 4163062, manufacturing date 2021-07-07, quantity (b)(4); tracheostomy tube assembly work order (b)(4) lot 4166185, manufacturing date 2021-06-21, quantity (b)(4); tracheostomy tube assembly work order (b)(4) lot 4166186, manufacturing date 2021-06-21, quantity (b)(4); 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.
Event or Problem Description
It was reported that one unit of portex 100/870/085 cannula unit was presenting defective.The balloon was emptying.A video of the reported problem was received, however no information was provided as to when the issue was found.The video shows the trach tube in a plastic cup of water/solution, with the cuff attempting to be filled, however air bubbles continue to come out of the balloon, and it does not fill up.No patient injury or involvement were reported.
Additional Manufacturer Narrative
Other, other text: h6: health impact and evaluation codes: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found there are some biological residues on the surface of sample and inside suction line which indicates that product was in use.No source of leak was visually found.Functional testing found it is not possible to inflate sample because it leaks so badly.Cuff tear was found under water.The root cause of the reported issue was found to be most probable that reported failure occurred during tracheostomy procedure due to contact with sharp edge.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; tambore ? santana de; minneapolis, MN 55442
• MDR Report Key: 14915829
• Report Number: 3012307300-2022-12879
• Device Sequence Number: 1881766
• Product Code: BTO
• UDI-Device Identifier: 15019315104879
• UDI-Public: 15019315104879
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 07/07/2026
• Device Model Number: 100/870/085CZ
• Device Catalogue Number: 100/870/085CZ
• Device Lot Number: 4163062
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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
• Patient Sex: Unknown