MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRACHEOSTOMY PVC - PORTEX TUBES PDT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/563/070

Device Problem Defective Component (2292)

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

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

Udi information is unknown.This remediation 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 total of five (5) product samples were received for evaluation.Visual inspection was performed.The evaluation received 5 components from the customer.The damage to the returned complaint object was confirmed.The sample for this complaint was sent to the manufacturing site, who will carried out a full investigation into the reported issue based on the sample which was returned.Oem evaluated the returned device for further analysis and upon visual inspection observed one tear in the cuff.A review of the manufacturing process was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.Inflation test was audited during thirty-two (32) units, in order to verify that the inflation test was properly performed; the inflation test was performed according to the test method stated in the manufacturing procedure; no deflated cuffs were detected during the thirty-two (32) units tested.The root cause was unable to be undetermined.Actions taken to mitigate the reported issue: no corrective action is required as there is no information to suggest that the product become damaged during manufacture since product is 100% deflated and inspection.A preventive action a notification to production personnel was conducted by the quality engineer in order to create awareness about failure mode issue reported by the customer.

Event Description

It was reported that the product was received in a damaged state.No patient injury was reported.

• Brand Name: TRACHEOSTOMY PVC - PORTEX TUBES PDT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; no-258/a, bomsandra indst. are; minneapolis, MN 55442
• MDR Report Key: 15599258
• MDR Text Key: 307035459
• Report Number: 3012307300-2022-23883
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

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 Operator: Health Professional
• Device Catalogue Number: 100/563/070
• Device Lot Number: 3556937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1