MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/897/090
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the connector to a smiths medical portex® uniperc® adjustable flange tracheostomy tube was disconnecting from the tube 11 days following placement.Subsequently, a trach tube change out was performed.There were no reported adverse effects.
Additional Manufacturer Narrative
Additional information d10, h3, h6.D5 is unknown.No information has been provided to date.Device evaluation: the device returned for investigation.A visual inspection of the device found that the joint between tube and connector showed excessive peeling in the bonded area.Functional testing confirmed the allegation.The connector was easily separated from tube once a small force was applied.The root cause can be attributed to an insufficient amount of solvent between connector and tube.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms # (b)(4).
Additional Manufacturer Narrative
Other, other text: additional information d10, h3, h6.D5 is unknown.No information has been provided to date.Device evaluation: the device returned for investigation.A visual inspection of the device found that the joint between tube and connector showed excessive peeling in the bonded area.Functional testing confirmed the allegation.The connector was easily separated from tube once a small force was applied.The root cause can be attributed to an insufficient amount of solvent between connector and tube.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147., corrected data: corrected information provided in d2.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, mn ; 3833310
• MDR Report Key: 9821035
• Report Number: 3012307300-2020-01869
• Device Sequence Number: 16536152
• Product Code: BTO
• UDI-Device Identifier: 15019315060458
• UDI-Public: 15019315060458
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/02/2022

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?: Yes
• Device Expiration Date: 11/08/2024
• Device Model Number: 100/897/090
• Device Catalogue Number: 100/897/090
• Device Lot Number: 3886456
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 07/14/2022; 07/14/2022; 09/01/2022
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 08/24/2022; 08/30/2022; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown