MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. BREATHING PORTEX GENERAL ANESTHESIA CIRCUITS

Catalog Number C37101329-NLJ

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Information received a smiths medical breathing|portex general anesthesia circuits during a pre-use check, the customer noticed air was leaking from the product considerably.It did not allow them to use the product.No patient injury.

Manufacturer Narrative

One sample was returned for analysis in used condition.During functional testing the circuit did not pass the leak test.Due to the fact that no lots of p/n c37101329-nlj were scheduled to be manufactured in the near future, per previous complaints a review of the manufacturing process for p/n c45031503d-nl, l/n 4032556 was conducted by quality engineer on 18/aug/2020, in order to verify that there are no situations or practices that could create the event as described in ?description of non-conformance? section.Both products are manufactured with the same manufacturing procedures, process controls and inspections.During the audit it was reviewed: 1.It was seen that production personnel performs a 100% leak test on the leak tester lt-4-2-072 using calibrated flow meters to measure the air outlet.During the test, if the corrugated tube is broken the unit failed the test.2.After the leak test, visual inspection was performed on the same samples to verify any damage on the components.A random sample of 32 units was taken from the manufacturing process, in order to perform a visual inspection to verify that all components were free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts or other workmanship defects that can affect assembly function or appearance.No discrepancies were detected.All the inspections and verifications are being performed by the production personnel and verified by the quality inspectors.Production personnel performs a 100% leak test for adult expandable circuits.Quality takes a sample using an aql 0.25 and level inspection gii per lot, in order to verify is free from damage, tubing is verify corrugations are not crushed or dented.Leak test is perform using aql 0.25 and level inspection gii per lot to ensure product does not leak.

• Brand Name: BREATHING PORTEX GENERAL ANESTHESIA CIRCUITS
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10408958
• MDR Text Key: 203708781
• Report Number: 3012307300-2020-08203
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: C37101329-NLJ
• Device Lot Number: 3962681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1