MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BREATHING ADAPTER AND CONNECTOR; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: d4: catalog number, lot number, expiration date, udi section, g5: 510k number and h4: manufacture date are unknown, no information has been provided to date.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 the swivel connector broke while disconnecting from the ventilator.No patient injury or adverse effects involved.

Manufacturer Narrative

H6 evaluation codes: updated no product was returned for investigation.Therefore, we are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation and a supplemental report will be sent.A review of the device history records could not be completed as no item/lot number was provided by the customer.

• Brand Name: PORTEX BREATHING ADAPTER AND CONNECTOR
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• 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: 17775697
• MDR Text Key: 323765381
• Report Number: 3012307300-2023-09038
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1