MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. AVON CBRN FILTER KIT PARTS; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE

Catalog Number 520A1227NFR

Device Problem Expiration Date Error (2528)

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

Event Type  malfunction  

Manufacturer Narrative

Udi and pma/510k are unknown; no additional information was provided.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; product return is not necessary for this investigation.The lot numbers and expiry dates on the products comply with the definitions and there is no requirement for the same expiry date to apply to all devices within a given batch.Applying an expiry date uniformly to a whole batch would result in kits with expiry dates that may not correspond to those of any of their constituent parts (in cases where the lot expiry is determined by older items present in other kits); and kits having to be discarded unnecessarily before their true, individual expiry dates.There is no non-conformance in this incidence.

Event Description

It was reported that expiration dates are different for 2 cartons of units with the same lot number (expiry dates 2022 and 2024).No patient injury was reported.

• Brand Name: AVON CBRN FILTER KIT PARTS
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15665567
• MDR Text Key: 306653758
• Report Number: 3012307300-2022-26104
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Catalogue Number: 520A1227NFR
• Device Lot Number: 3780665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1