MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number CA24K0/000/000JP

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: month and year of event have been provided; day is unknown.D4: expiration date and h4: manufacture date is unknown; no information is available based on reported lot number.D4.Udi number is unknown, no information has been provided to date.G5: 510k is blank device is exempt.One used (pre-use check) device in the original package was returned.Visual inspection noted a tear in the corrugated tube at the location marked by the customer on the corrugated tube.Upon magnifying and observing the tear, it was likely caused by a protruding object.Review of the kiting process did not reveal any factors that could have caused the tear, as no tools were used.It was also unlikely that the damage was caused during transportation.A root cause determined that a tear occurred before being supplied to the distributor.A device history record (dhr) review found no discrepancies or anomalies.The returned device has been sent to a secondary manufacturing facility for further device analysis.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that there was a circuit leak.When a preliminary check was performed a leak was found so use was discontinued.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Evaluation codes: updated.Four photos and one device were received without original packaging.A visual inspection did not detect any issue which could cause the reported leak.A leak was detected during functional testing confirming the complaint.The root cause was due to a perforated corrugated tube from manufacturing.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will continue to be monitored and further actions taken accordingly for threshold or escalation.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17221879
• MDR Text Key: 318085364
• Report Number: 3012307300-2023-06831
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA24K0/000/000JP
• Device Lot Number: 220714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2023
• 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