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

Catalog Number CA16K0/400/000JP

Device Problem Fracture (1260)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: month and year of event have been provided, day is unknown.D4: lot number, expiration date, udi number and h4: device manufacture date is unknown, no information has been provided to date.G5: 510k is blank, device is exempt.One device was returned.Per visual inspection, there was a crack in the y-connector.It was suspected that the defect occurred before being supplied to the affiliate site.A device history record (dhr) review could not be performed as the lot number was unknown.The device was sent to a secondary site 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 during a pre-use check the device had a cracked connector.

• Brand Name: PORTEX ANESTHESIA CORRUGATED BREATHING CIRCUIT
• 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: 18031637
• MDR Text Key: 326871461
• Report Number: 3012307300-2023-10023
• 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
• Report Date: 10/30/2023

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 Catalogue Number: CA16K0/400/000JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1