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

Lot Number 210702

Device Problem Defective Device (2588)

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

Event Date 09/01/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of air from the breathing circuit was observed.No patient injury was reported.

Manufacturer Narrative

Leak test results: leak test inspection was performed on the returned device using equipment manometer id# 8.0324 (calibration due date 07/2022).Results: the device presented leakage.Conclusions: based on the leak test results, the reported nonconformance is confirmed.Root cause: per trend review as leakage failure an escalation was performed to investigate this failure and determine the root cause.Escalation was initiated on (b)(6) 2021 under (b)(4).Current ncr status - risk evaluation (hra) action taken: corrective actions will be addressed and implemented trough (b)(4), all occurrence and detection mitigations are placed in process.Dhr: the lot 4115552 was manufactured with (b)(4) units, lot met the requirements to release the lot with no deviations identified during their manufactured.

• Brand Name: PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 13443822
• MDR Text Key: 287618520
• Report Number: 3012307300-2022-02479
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 210702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1