MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; OPHTHALMIC, ANESTHESIA, RESPIRATORY

Model Number	100/136/070
Medical Device Problem Codes	Material Puncture/Hole (1504); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pre-use check, the customer found a pinhole in the base part of the tube's inflation line.No patient injury.
Event or Problem Description
Investigation completed.This event occurred prior to usage, no patient involvement.The procedure of assessing inflation is followed by medical personal as part of procedure and recommended by manufacture.
Additional Manufacturer Narrative
Investigation completed on a smiths medical intubation|portex endotracheal tubes polar three photos received.One sample p/n 100/136/070; visually inspected under normal distance under specification and hole was detected in the tube.The product was testing and upon submerging under water leakage was detected where the inflation line is assembled.The device engineering was reviewed and revealed passing at 100% prior to release.However this event could have occurred during assemble but not confirmed.Per md01-003 rev.101 production personnel performs a 100% visual inspection to inspect the following: parts shall not be damaged (including scratches) or distorted/warped.Verify part (or assembly) has the correct components, features, elements and/or shape.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.

• Brand Name: PORTEX
• Common Device Name: OPHTHALMIC, ANESTHESIA, RESPIRATORY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10999945
• Report Number: 3012307300-2020-12329
• Device Sequence Number: 3487402
• Product Code: BTR
• UDI-Device Identifier: 15019315021312
• UDI-Public: 15019315021312
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: 02/07/2025
• Device Model Number: 100/136/070
• Device Catalogue Number: 100/136/070
• Device Lot Number: 3927035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1