MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC TRACHEOSTOMY SILICONE - BIVONA TUBES CUSTOM; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number CUSTOM 6.0 TTS FLEXTEND

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: testing/inspection: sample received: one (1) sample was received from p/n 60pfss40 l/n 3632007 without its original packaging inside a (b)(6) bag, with its certificate of decontamination and in used conditions.Visual inspection: visual inspection was performed at 12" under normal conditions of illumination in order to detect any damage on the part.Results: during the visual inspection, it was seen that the flange was broken.Other analysis the following are relevant documents, which were reviewed and considered adequate and correct for testing and inspection activities: · mp bivona tt-tj110 rev.108 - flextend tts tracheostomy tube assembly.· mp bivona tt-tj040 rev 106 - manual cleaning process.· 10018858-001 rev.100 ifu-flextend tracheostomy (flx).· qp bivona tt-fg-tj rev.112 - inspection for bivona finish goods.Per previous complaint, a review of the manufacturing process for p/n 60pfps60 and l/n 3874296, was conducted by quality engineer on (b)(6) 2020 in order to verify that there are no situations or practices that could create the event as described in "description of non-conformance" section.All procedures are being carried appropriate.Note: both p/n 60pfs60 and is from the same product family that the product reported in this complaint.The assembly process was performed according to the procedures listed above.The training was reviewed and it was confirmed that the personnel had the trainings up to date.During the verification, 32 assemblies were reviewed to see if they had a molding issue such as "short shot, cuts, split, voids or bubble" according to qp bivona tt-fg-tj rev.112 - inspection for bivona finish goods and av-10003878 rev.101 - visual aid for bivona criteria, no damage was detected on the units.All the inspections and verifications are being performed by the production personnel and verified by the quality inspectors.The instructive "10018858-001 rev.100 ifu-flextend tracheostomy (flx)." was reviewed.· on section 4.8 states: "do not use a tube that is cut or damaged.Use of a damaged tube can result in airway compromise.This device must be thoroughly inspected for signs of damage or wear prior to each use." see image below for evidence: · on section 4.10 states: "guard against product damage by avoiding contact with sharp edges.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity.A damaged eyelet can result in decannulation of the tracheostomy tube.We recommend using the twill tape holder supplied with the product." see image below for evidence: mitigation · production personnel reviews the parts 100% before assembling them to see if they have any molding issue such as: short shot, cuts, split, voids or bubbles in the critical areas of the neckstrap.· quality takes a representative sample and performs a visual inspection to review for: short shots, chips or cuts in critical areas of the neckstrap, after each process.Root cause customer reported that: "the trach had to be emergently changed due to the eyelet being torn." after a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause is that damaged occurred after the product left the shm facility.Action taken: as a preventive action production personnel was notified by quality engineer on (b)(6) 2020 as awareness of the defect reported by the customer.Investigator name: (b)(6).Investigator title: quality engineer.Date (b)(6) 2020.

Event Description

Information received a smiths medical silicone - bivona tubes custom tracheostomy tube eyelet of the trach end tore.This is a end part of the phalange where tie would go to hold in placed.This event could cause the person to have decannulation and compromise airway control.No patient adverse events reported.

• Brand Name: TRACHEOSTOMY SILICONE - BIVONA TUBES CUSTOM
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue,; gary, in
• Manufacturer Contact: dave halverson ; 6000 lane n; minneapolis, mn ; 3833310
• MDR Report Key: 9945809
• MDR Text Key: 188464094
• Report Number: 3012307300-2020-02914
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CUSTOM 6.0 TTS FLEXTEND
• Device Catalogue Number: FT19EN60NGC076N
• Device Lot Number: BS003551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention