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

Catalog Number C37101329-NLJ

Device Problems Inadequacy of Device Shape and/or Size (1583); Incomplete or Missing Packaging (2312)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported that the "packed anesthesia bag was not 3l".Discovered during a pre-use check.

Manufacturer Narrative

Other text: d4: udi number is unknown; no information has been provided to date.G5: 510k is blank, device product code is 510k exempt.D3, g1,2 email is: (b)(6).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Email is: regulatory.Responses@icumed.Com.One device sample was received without the original packaging.Two photos were included for evaluation; photos show a breathing bag with capacity of 1 liter instead of the 3 liters.The returned sample was reviewed and compared with the bill of materials (bom) corresponding to the part number reported and confirmed that the correct size of the breathing bag is 3 liters instead of 1 liter.The complaint was confirmed and due to manufacturing.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The fault was considered an isolated event.The manufacturer will continue monitoring this failure condition for threshold or escalation.

• 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: reed covert
• MDR Report Key: 18283869
• MDR Text Key: 329952245
• Report Number: 3012307300-2023-10947
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C37101329-NLJ
• Device Lot Number: 4393840
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1