MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE, NON-REINFORCED, NON-CUSTOMIZED,

Model Number	60PFS40
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Testing/inspection: the received sample was in new conditions inside its closed original packaging.Visual inspection was performed at 12" under normal lighting results: a hair was observed inside the closed packaging.The complaint is confirmed.There were two available models of disposable cover hair in production floor, however, one did not meet the function of retaining hair because it was too short.Action taken: ehs department were notified about the inadequate disposable cover hair.Large model was bought to replace the inventory of short model, inadequate disposable cover hair (short model) was removed from production floor.The production personnel was notified by quality engineer as awareness of the defect reported by the customer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
Event or Problem Description
It was reported that there was presence of hair in the sterile packaging: no patient injury was reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE, NON-REINFORCED, NON-CUSTOMIZED,
• 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: 15437199
• Report Number: 3012307300-2022-19424
• Device Sequence Number: 14914082
• Product Code: JOH
• UDI-Device Identifier: 15021312005868
• UDI-Public: 15021312005868
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Pharmacist
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2025
• Device Model Number: 60PFS40
• Device Catalogue Number: 60PFS40
• Device Lot Number: 3942505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown