MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY; NEONATAL/PEDIATRIC TRACHEOSTOMY

Model Number	60PFSS45
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon opening the package, the label lists a straight flange but the trach received had a v-flange.No patient involvement.
Additional Manufacturer Narrative
Three (3) samples were received from p/n 60pfss45 l/n 3991195 in unused conditions inside their closed original packaging.In addition, one photo was received and it was observed that products inside the trays don't match labeling, labeling is for a product with a straight flange and the product inside the tray has a ?v" flange.The reported customer complaint is confirmed from visual inspection of the photo and samples received.A device history review was performed and it was found that the reported part and lot number was assembled correctly according to its bill of materials and labeling.The reported issue is a known issue and a corrective and preventative action has been opened to address the confirmed failure.D5 and e4 is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA TRACHEOSTOMY
• Common Device Name: NEONATAL/PEDIATRIC TRACHEOSTOMY
• 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: 15437196
• Report Number: 3012307300-2022-19425
• Device Sequence Number: 5844987
• Product Code: JOH
• UDI-Device Identifier: 15021312516791
• UDI-Public: 15021312516791
• Combination Product (Y/N): N
• 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): 09/16/2022

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
• Device Expiration Date: 06/27/2025
• Device Model Number: 60PFSS45
• Device Catalogue Number: 60PFSS45
• Device Lot Number: 3991195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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