MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX CRICOTHYROIDOTOMY; NEEDLE, EMERGENCY AIRWAY

Model Number	100/465/060
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that some of the peremption dates of batches that are not matching with the boxes of goods received.No patient injury or involvement was reported.
Additional Manufacturer Narrative
One sample was received at the investigation site in its original packaging.Expiry dates on labels versus expiry dates in system versus expiry dates in purchase order were compared and it was found that there is mismatch.Expiry dates on labels are correct but expiry dates in the system are incorrect.Root cause related to quality control.A review of the device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.All expiry dates within dhrs are correct.No information has been received to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX CRICOTHYROIDOTOMY
• Common Device Name: NEEDLE, EMERGENCY AIRWAY
• 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; minneapolis, MN 55442
• MDR Report Key: 15409666
• Report Number: 3012307300-2022-18871
• Device Sequence Number: 5512648
• Product Code: BWC
• UDI-Device Identifier: 15019315010989
• UDI-Public: 15019315010989
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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 Model Number: 100/465/060
• Device Catalogue Number: 100/465/060
• Device Lot Number: 3820782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown