MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL FLEXTEND; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 60PFS40

Device Problem Material Too Rigid or Stiff (1544)

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

Event Type  Injury  

Event Description

It was reported that the obturator was stiff.No patient harm, the tube was not used on the patient.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three (3) samples were returned, and two of the samples had damaged flanges (sample 2 and 3).The failure reported could not be reproduced using tools from the assembly process.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from molding or assembly.Therefore, the damage (hole) occurred after the product left the facility.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process., corrected data: b1 updated to serious injury.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.Three used samples were received without their original packaging, with their certificate of safe handling and their obturator.During the visual inspection, two samples were found with a damaged flange.The root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from molding / assembly process.The damage occurred after the product left the manufacturing facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: BIVONA UNCUFFED NEONATAL FLEXTEND
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14471435
• MDR Text Key: 292388089
• Report Number: 3012307300-2022-09429
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312005868
• UDI-Public: 15021312005868
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60PFS40
• Device Catalogue Number: 60PFS40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention