MAUDE Adverse Event Report: DEPUY MITEK LLC US 1572 2.5MM FMS CANNULA PK/20 -SH; ARTHROSCOPIC ACCESS CANNULA, SINGLE-USE

Model Number 281572

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Distributor has reported the following case: please note that we noticed that the expiry date mentioned on the label is different than the one included in the barcode (and mentioned on the related packing list as well).

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information provided, it was reported the following case: please note that we noticed that the expiry date mentioned on the label is different than the one included in the barcode (and mentioned on the related packing list as well).Below you can find the details of the affected products we have found in stock: fms outflow cannula-code:281572- lot number: 62795.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it was observed that the expiry date mentioned on the label is different than the one included in the product label barcode / packing list.The expiry date (barcode) for lot number 62795 states 30-12-2019, however the expiry date on the product label states 30-12-2020.A nonconformance was opened to track this failure with the supplier.A stop shipment was initiated (281572) for the lot number impacted.Quality, medical safety and regulatory affairs reviewed the investigation and determined that this product nonconformance presents no increased risk to patient safety nor does it after the product benefit-risk profile.The root cause stems from supplier label software system, the product code 281752 is received into depuy mitek neuchatel site where label is checked, however the expiry date is manually inputted into the erp system.The corrective action was made in supplier site (harmac) where implemented a label software verification step that is deployed a whenever a label¿s software is changed.As part of this verification, the new label is printed and then reviewed by the cognizant engineer who approved the change on the software verification form.A device history review was conducted for the lot involved without any related findings.At this point in time, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: 1572 2.5MM FMS CANNULA PK/20 -SH
• Type of Device: ARTHROSCOPIC ACCESS CANNULA, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10532516
• MDR Text Key: 207940331
• Report Number: 1221934-2020-02611
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10886705016310
• UDI-Public: 10886705016310
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2019
• Device Model Number: 281572
• Device Catalogue Number: 281572
• Device Lot Number: 62795
• Date Manufacturer Received: 11/25/2020
• Patient Sequence Number: 1