MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	60PFS50
Medical Device Problem Code	Device Damaged Prior to Use (2284)
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 b10010116, as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of sample received was in used condition, without its original packaging and with its certificate of safe handling.The sample was visually inspected at twelve inches under normal lighting.As part of the investigation three images were also provided.According to the visual inspection, condition reported in complaint is visible; however, this does not assure us that there exists a failure on the process, the exposed wire was produced by improper handling of the device, as it has rips at the end of the tube.This condition can be attributed to incorrect handling of the device.Based on this the failure mode cannot be confirmed; however, no complaint for failure mode was reported.The following are relevant documents which were reviewed and deemed adequate and correct with respect to assembly inspection: manufacture procedure tube shaft uncuffed and cuffed inspection for bivona finish goods.Controls are: steps establish that the operator must make the visual inspection of all shots produced.Inspect molded tubes 100 percent for exposed wire by following visual aid.Steps also establish that no short shots, cuts or splits in critical areas, using an inspection level.Based on the tests performed to replicate the failure mode, where it could not be reproduced using the tools from assembly process, the most probable root cause by improper handling of the device, as it has rips at the end of the tube.This condition can be attributed to incorrect handling of the device.Actions taken to mitigate the reported: no corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.
Event or Problem Description
It was reported that the wire and or spring is sticking out on the end of the tracheostomy.The customer did not place the item in their body because they were concerned about the wire that was hanging out.No patient injury reported.

• Brand Name: SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS
• 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: 16077735
• Report Number: 3012307300-2022-28312
• Device Sequence Number: 6294578
• Product Code: JOH
• UDI-Device Identifier: 15021312005882
• UDI-Public: 15021312005882
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2022

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: 60PFS50
• Device Catalogue Number: 60PFS50
• Device Lot Number: 4096826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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