MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ULTRAPERC PDT TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 100/563/070

Device Problem Leak/Splash (1354)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

E4 is unknown, no information provided to date, g5 is unknown, h6: event problem and evaluation codes: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found tear damage on the cuff, thus the failure mode reported is confirmed.Functional testing of the sample received was inflated according to the recommendations with air using a syringe in order to evaluate the cuff, then was immersed in the water in order to detect any leakage.Cuff was unable stay completely inflated leak was detected in damage on cuff; thus, failure mode is confirmed.After review of the different verifications that are performed during the manufacturing process to detect damage component, the most probable root cause is that damaged occurred after the product left the manufacturer facility.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

Event Description

It was reported of leakage on the cuff.Additional information received via customer response email 14-jul-2022: it was noted there was patient injury and medical intervention.Could you please let us know what medical intervention was required? change of the tubes during insertion.No additional information is available due to pdpa concern.

• Brand Name: PORTEX ULTRAPERC PDT TUBES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16693974
• MDR Text Key: 312857468
• Report Number: 3012307300-2023-03702
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2023
• Device Catalogue Number: 100/563/070
• Device Lot Number: 3973791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other