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

Model Number 67PFSS45

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), 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.One (1) picture was received.According to pictures above, it was seen a small hole in the cuff.One (1) sample was received without its original packaging inside a ziploc bag.Sample was inspected at 12 under normal lighting to received unit, in order to detect any damage on the cuff or airline.During the visual inspection, it was seen a small hole in the cuff.The sample was tested on leak test.The test was performed under water as per procedure.Testing the sample received found leak in the cuff.The most probable root cause was that when taking out some parylene flash the unit was damaged.Actions taken, procedures are being in order to add after cleaning and before packaging, if the piece needs to be rework by flash, the unit has to be tested (leak test) to make sure that was not affected.Production personnel was notified by area trainer as awareness of the defect reported by the customer.

Event Description

It was reported that upon testing, a small hole was found that caused leakage in the balloon.No patient injury was reported.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• Type of Device: 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; 11 yip hing street; minneapolis, MN 55442
• MDR Report Key: 15658941
• MDR Text Key: 306783246
• Report Number: 3012307300-2022-26052
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518705
• UDI-Public: 10351688518705
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: 67PFSS45
• Device Catalogue Number: 67PFSS45
• Device Lot Number: 3526580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1