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

Catalog Number C37101304J

Device Problem Gas/Air Leak (2946)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: month and year have been provided.Day is unknown.D4: udi section, lot number, expiration date and h4: manufacture date are blank.No information has been provided to date.G5: 510k is blank, device is exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr, 803.56 when required.

Event Description

It was reported, that during the pre-use check.Leakage of air from the product was observed.No adverse patient effects were reported by the customer.It was reported, that no additional information is available for this event.

Manufacturer Narrative

Other, other text: d10, h6 evaluation codes: updated one device and three photos were returned for investigation.The returned sample was visually and functionally inspected.Per inspection, it was confirmed a damage in the corrugated tube caused the leaking failure mode.The occurrence of this failure condition could be caused by over handling of the product.A review of the device of the device history records could not be completed as no lot number was provided by the customer.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT, STRAIGHT CONN
• 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: 17034893
• MDR Text Key: 316281368
• Report Number: 3012307300-2023-05918
• 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: 06/23/2023

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: C37101304J
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1