MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOMIZED TRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	67PFPS50
Medical Device Problem Codes	Material Puncture/Hole (1504); Tear, Rip or Hole in Device Packaging (2385)
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# (b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.One (1) sample was received without its original packaging inside a ziploc bag.Visual inspection was performed at 12 under normal lighting to received unit, in order to detect any damage on the cuff.No damage could be detected on cuff.The sample was tested on leak test.The test was performed under water per procedure.During the test, it was found a leak in the inflation line.A second inspection was performed after the leak test and it was observed a hole in the inflation line.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the root cause of the reported issue could not be confirmed during evaluation; however, the most probable root cause is that damage occurred after the device left the manufacturing site.As a preventive action production personnel was notified by area trainer as awareness of the defect reported by the customer.
Event or Problem Description
It was reported that the technician stated upon first reprocessing, a hole was found in the trach's shaft.No patient injury was reported.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 15591511
• Report Number: 3012307300-2022-23592
• Device Sequence Number: 2236567
• Product Code: JOH
• UDI-Device Identifier: 10351688518569
• UDI-Public: 10351688518569
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: 67PFPS50
• Device Catalogue Number: 67PFPS50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• 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