MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; BREATHING-CIRCUIT

Model Number C37101329-NLJ

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, a pinhole was found in the product, from where leakage of air was detected.No patient injury.

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.A product unit was received for evaluation.Unit returned was received inside of a plastic bag.During visual inspection, it was noticed that the unit was damaged.During functional testing, the unit was submitted to leak testing per the procedure using an equipment manometer and the unit presented leakage.The complaint was confirmed.An escalation was performed for leakage failure to investigate and determine the root cause.All corrective actions will be addressed and implemented through a non-conformance.Additional information: d3, d4 (udi), g2, g5 are unknown., corrected data: d1.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: BREATHING-CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 12712441
• MDR Text Key: 278813627
• Report Number: 3012307300-2021-10383
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: C37101329-NLJ
• Device Catalogue Number: C37101329-NLJ
• Device Lot Number: 4135597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1