MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX (SACETT) SUCTION ABOVE THE CUFF TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR) PRODUCT CODE: BTR

Catalog Number	100/189/085
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: foreign, (b)(6).
Event or Problem Description
Information was received that after intubation of a a smiths medical portex (sacett) suction above the cuff tracheal tube, the inflation line pulled out of the tube when the customer inflated the cuff.Subsequently, a trach tub change out was required.No adverse patient effects were reported.
Additional Manufacturer Narrative
Device evaluation: one portex tracheal sample was received in used condition without its original packaging.Immediate visual inspection detected that the inflation line was completely detached with residues of solvent only in the tip.Operator training records were reviewed to ensure operators are trained in bell-out, fit inflation line, and pressure decay tests.No discrepancies were found.The pressure decay tests and fit inflation line operations were also audited during thirty two (32) units finding no discrepancies and no inflation lines detached.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and investigation, the complaint was confirmed.The problem source was stated to be manufacturing and it was noted the most probable sources of the reported event were either of the following: insufficient solvent due to inflation line not correctly inserted into the dispenser or a lack of detection by production personnel who performs the fit of inflation line to tube.Retraining was completed by the quality engineer and production supervisor for - bell out, fit inflation line, inflate cuff, and pressure decay test, emphasizing that the correct placement of the inflation line into the solvent dispenser and to ensure that the thf level rises and wets the exterior of the line.Additionally, an image was added to the visual aid to show that the inflation line must be submerged vertically until it reaches the bottom and must be removed quickly.

• Brand Name: PORTEX (SACETT) SUCTION ABOVE THE CUFF TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR) PRODUCT CODE: BTR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8553433
• Report Number: 3012307300-2019-02263
• Device Sequence Number: 19410294
• Product Code: BTR
• UDI-Device Identifier: 15019315059551
• UDI-Public: 15019315059551
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 100/189/085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention