MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEAL TUBE

Model Number	100/133/075
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device cuff did not inflate.No adverse effects reported.
Additional Manufacturer Narrative
Other, other text: additional information updated d 3 and h 4.
Event or Problem Description
Additional information on lot number 3858243.
Additional Manufacturer Narrative
Other, other text: no product was returned.If the product is returned, smiths medical will reopen this complaint for further investigation.The following are relevant documents which were reviewed and deemed adequate and correct with respect to testing and inspection activities: mp tpol-tj085 rev.003 polar tracheal tube - assemble dry cuff to thracheal tube.Mp tpol-tj130 rev 104 polar tracheal tube - bell out, fit inflation line, inflate cuff and pressure decay test.Qp tpol-tj rev 105 tracheal polar line assembly and packaging.Rmp 1059 rev.000 - risk management plan for polar tracheal tubes.10016024-002 rev.100 ? instructions for use - tracheal tubes.According to rmp 1059 rev.000 appendix 1 ?pfmea for polar tracheal tubes? the occurrence for this failure condition could be caused by: 1) method not followed (the operator did not remove the thf excess from the inflation line) for this occurrence the mitigation to detect this are: per mp tpol-tj130, 100% leak and evacuate test in line and 100% visual inspection.Per qp tpol-tj visual inspection, leak and evacuation test, aql 1.0/g-i per mp tpol-tj130 rev 104: production performs a 100% visual inspection and inflation test to the inflation line and the cuff.Per qp tpol-tj rev 105: quality takes a sample using an aql 1.0 and a level inspection g-i in order verify the visual inspection and audit leak test.Customer reported: ?cuff failed to inflate in 4 consecutive nasal endotracheal tubes.No root cause could been determined since the complaint was not confirmed due to the fact that no samples, pictures or videos were received to perform a thorough investigation.No actions taken were performed since the complaint was not confirmed.
Event or Problem Description
Investigation completed and summarized in h 10.
Event or Problem Description
Investigation completed and summarized.
Additional Manufacturer Narrative
Other text: no product was returned.If the product is returned, smiths medical will reopen this complaint for further investigation.The following are relevant documents which were reviewed and deemed adequate and correct with respect to testing and inspection activities: mp tpol-tj085 rev.003 polar tracheal tube - assemble dry cuff to thracheal tube.Mp tpol-tj130 rev 104 polar tracheal tube - bell out, fit inflation line, inflate cuff and pressure decay test.Qp tpol-tj rev 105 tracheal polar line assembly and packaging.Rmp 1059 rev.000 - risk management plan for polar tracheal tubes.10016024-002 rev.100 instructions for use - tracheal tubes.According to rmp 1059 rev.000 appendix 1? pfmea for polar tracheal tubes? the occurrence for this failure condition could be caused by: 1) method not followed (the operator did not remove the thf excess from the inflation line) for this occurrence the mitigation to detect this are: per mp tpol-tj130, 100% leak and evacuate test in line and 100% visual inspection.Per qp tpol-tj visual inspection, leak and evacuation test, aql 1.0/g-i per mp tpol-tj130 rev 104: production performs a 100% visual inspection and inflation test to the inflation line and the cuff.Per qp tpol-tj rev 105: quality takes a sample using an aql 1.0 and a level inspection g-i in order verify the visual inspection and audit leak test.Customer reported: cuff failed to inflate in 4 consecutive nasal endotracheal tubes.No root cause could been determined since the complaint was not confirmed due to the fact that no samples, pictures or videos were received to perform a thorough investigation.No actions taken were performed since the complaint was not confirmed.

• Brand Name: PORTEX
• Common Device Name: TRACHEAL TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent MN CT21 6JL; UK CT21 6JL
• MDR Report Key: 10764366
• Report Number: 3012307300-2020-10853
• Device Sequence Number: 19117214
• Product Code: BTR
• UDI-Device Identifier: 15019315020360
• UDI-Public: 15019315020360
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/09/2020

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: No Information
• Device Expiration Date: 08/01/2024
• Device Model Number: 100/133/075
• Device Catalogue Number: 100/133/075
• Device Lot Number: 3858243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 11/10/2020; 11/12/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/07/2020; 12/08/2020; 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1