MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Lot Number 3973607

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

Several circuits from the same lot have the filter missing.

Manufacturer Narrative

Testing/inspection: one unit was returned for evaluation of the failure and pictures by the customer was not provide it.Unit returned was received inside of a plastic bag which is their original package sample was submitted to visual inspection base on (b)(4) rev.100 - adult disposable anesthesia breathing circuit 2 x 72"" (183cm) tubes results: customer reported circuits from the same lot have the filter missing? reviewing the sample returned, the filter is in the bag but is not installed with the elbow.Failure description must be loose filter: see pictures attached on the investigation: conclusions: based on the inspection, it can't be confirmed failure mode as missing filter but can be confirmed as loose filter.Root cause: cannot be confirmed the failure, the most probable root cause is that loose filter occurred after the product left smiths medical facilities.Action taken: no corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process dhr: lot 3973607 was manufactured with (b)(4) units; lot met the requirements to release the lot with no deviations identified during their manufactured.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 13425515
• MDR Text Key: 286566990
• Report Number: 3012307300-2022-02371
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2023
• Device Lot Number: 3973607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1