MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX GENERAL ANESTHESIA CIRCUIT; CIRCULATOR, BREATHING-CIRCUIT

Catalog Number C45101340-NLJ

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Lot number: lot contains the following possible numbers: 180528.(b)(6).Device evaluation: one breathing circuit was received for investigation.The sample was received in used condition without its original packaging.Immediate visual inspection detected a hole in the product.A leak functional test was completed and the device did not pass.In addition, leak tests were audited in order to verify that all components were free of damage or defects.Thirty two (32) units were reviewed and no discrepancies were found.A review of the manufacturing process was also conducted and was considered adequate and correct.Based on the evidence and testing, the complaint allegation was confirmed.The root cause was listed as unknown.

Event Description

Information was received that a smiths medical portex general anesthesia circuit had a small pinhole leak while in use.The issue was discovered after hearing an air leak sound and it was reported they were able to cover the pinhole with tape.No adverse patient effects were reported.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUIT
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8401517
• MDR Text Key: 138159211
• Report Number: 3012307300-2019-01275
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101340-NLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1