MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX RESPIRATORY FILTERS HEPA; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number 62.002.0079.4244/711CRSA

Device Problem Break (1069)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.This is a supplied item and the dhr will be done at the supplier.

Event Description

It was reported that during the pre-use check, the sampling connector was found broken from the base.No patient injury.No additional information is available for this complaint.

• Brand Name: PORTEX RESPIRATORY FILTERS HEPA
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 13514119
• MDR Text Key: 285822091
• Report Number: 3012307300-2022-03202
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 15019315083297
• UDI-Public: 15019315083297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033008
• 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: 02/11/2022

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 Model Number: 62.002.0079.4244/711CRSA
• Device Catalogue Number: 2874
• Device Lot Number: LT2011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/11/2022
• 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