MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TRACHEOSTOMY TUBE HOLDERS; SUPPORT, BREATHING TUBE

Catalog Number 520001

Device Problem Material Separation (1562)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that two units when removed from the primary packaging, were unsewn.There was no patient involvement and no harm or adverse event reported.

Manufacturer Narrative

No product was returned.We are unable to confirm the reported complaint.Additionally, photos were reviewed by the supplier, and the supplier concludes that the photos do not correspond to the reported part number.The device history record (dhr) is at the supplier and not readily available for review.If the product is returned the complaint will be re-opened for further device analysis.G1 - contact office email.

• Brand Name: PORTEX TRACHEOSTOMY TUBE HOLDERS
• Type of Device: SUPPORT, BREATHING TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 9124 polk ln, suite 101; olive branch MS 38654
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18528134
• MDR Text Key: 333053397
• Report Number: 3008818980-2024-00002
• Device Sequence Number: 1
• Product Code: JAY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 520001
• Device Lot Number: U2024727
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1