MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INTUBATION CATHETER MOUNT DOUBLE SWIVEL CONNECTOR; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 100/594/000

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the customer stated the corrugated tube does not fit.There was a patient involved."there is no information if there was harm or injury.".

Manufacturer Narrative

Other text: b3: date of event and d4: udi section are unknown, no information has been provided to date.G5: 510k is blank, device is exempt.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.

Manufacturer Narrative

Device evaluation: no product was returned for evaluation.A video was provided which shows the product attempting to be connected to the infant patient and the device does not stay connected to the tracheostomy connector.The complaint was able to be confirmed based on the provided video however a root cause cannot be confirmed without the physical device being available for evaluation.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the device is later returned, the complaint will be reopened and an investigation will be completed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: INTUBATION CATHETER MOUNT DOUBLE SWIVEL CONNECTOR
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17761375
• MDR Text Key: 323726703
• Report Number: 3012307300-2023-08975
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 100/594/000
• Device Lot Number: 4185151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1