MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOMIZED TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67PFPS45
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.Two (2) pictures were received, according to the pictures received.It was seen that the unit has small fibers of material in the neck strap.One (1) sample was received without its original packaging inside a ziploc bag.Visual inspection was performed at 12 under normal conditions of illumination in order to detect any damage on the part.It was observed that the sample had excess of parylene.Additional it was tried to remove the excess of parylene using a glove.Parilene was easy removed from the unit.It was seen that productions personnel performs a 100% visual inspection during the assembly process in order to verify that the adhesive is free of contamination.Production personnel performs a 100% visual inspections before to cleaning the units in order to verify that parts are free of defects according to procedures.Quality inspectors takes a representative sample of the lot and performs a visual inspection in order to detect any contamination on the units and flacking or peeling of parylene was not acceptable on entire part.The most probable root causes are excess of parylene was produced during the superslick process since the racks was not clean correctly.The excess of parylene was produced during the superslick process since the quartz wasn?t clean correctly and it was dirty.The following actions were taken per previous complaints, as correctly actions, 6 quartz where purchased to have a backup and to make sure they had the time to clean them well.Per previous complaint, procedure was updated in order to include as part of the cleaning of the superslick, the cleaning of the rack that support the delring fixtures to prevent particulates on pieces.Per previous complaint, as mitigation a procedure was generated to ensure that racks has to be clean of parylene fibers to avoid contaminations on the units.As preventive action, production personnel was notified by area trainer on as awareness of the defect reported by the customer.
Event or Problem Description
It was reported that the trach never made it through first process.The technician noticed during pre-steam that the silicone on the neck flange began flaking and peeling off.No patient injury was reported.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15591302
• Report Number: 3012307300-2022-23582
• Device Sequence Number: 19350827
• Product Code: JOH
• UDI-Device Identifier: 10351688518552
• UDI-Public: 10351688518552
• Combination Product (Y/N): N
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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: Health Professional
• Device Model Number: 67PFPS45
• Device Catalogue Number: 67PFPS45
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown