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

Catalog Number C45101340-NLJ

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reported that before opening the package, the customer found an insect in it.No patient injury was reported.No additional information is available.

Manufacturer Narrative

A product sample was received and is awaiting evaluation and 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.Protocol # and the udi are unknown, no product information has been provided to date.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.Four (4) pictures were attach, during the analysis conducted it could be observed a top view of a circuit breathing inside of sealing packaging, two of them is made a focus to a section where foreign matter that looks like parts of insect is observed.Visual inspection results: the bag of the circuit breathing is sealed and a particle of foreign matter that looks like part of insect was detect; thus failure mode reported is confirmed.Additionally, the plastic bag of the sample returned it was inspected and confirmed the presence of 2 holes, which is within specification; this both holes were received cover with tape and position is close to the connector which contamination was detected.However, due bag has an opening it can not be confirmed that the defect was caused during the manufacturing process.The most probable root cause occurred after the product left smiths medical facilities.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.

• Brand Name: PORTEX ANESTHESIA 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 15250029
• MDR Text Key: 305090840
• Report Number: 3012307300-2022-15590
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101340-NLJ
• Device Lot Number: 4236537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1