MAUDE Adverse Event Report: FHC, INC. STERILE DRAPE SLEEVES

Model Number E5-81

Device Problem Expiration Date Error (2528)

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

Event Date 07/28/2014

Event Type  malfunction  

Event Description

An expiration date discrepancy of sterile drape sleeves, model e5-81, lot 150117, was found during an internal audit.Vendor paper work shows an expiration date of february 2018.The internal inventory and sales system shows an expiration date of may 4, 2017.Products made from this lot show an expiration date of may 4, 2018.(b)(4) products were made (catalog #66-da-sd and fc1004).(b)(4) units were shipped to (b)(4) different customers (packaged 20 units to a box).A product hold was immediately placed on the remaining internal stock, which was relabeled with the correct february 1, 2018 expiration date.Therefore, the (b)(4) customers who had purchased the product were contacted via phone or personal visit on (b)(6) 2014 to issue a market withdrawal.The communication was followed-up with a formal market withdrawal letter.A process change was implemented and will be tested with the next vendor shipment of e5-81 drape sleeves.

Manufacturer Narrative

(b)(4).Despite several attempts to contact the customer, fhc has had no reply communication regarding the status of the with product.All unopened returned boxes were relabeled with the correct expiration date.Opened boxes of product were destroyed.

• Brand Name: STERILE DRAPE SLEEVES
• Type of Device: STERILE DRAPE SLEEVES
• Manufacturer (Section D): FHC, INC.; bowdoin ME
• Manufacturer Contact: kathy mills ; 1201 main st; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 4080917
• MDR Text Key: 4825154
• Report Number: 3005677147-2014-00008
• Device Sequence Number: 1
• Product Code: MMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: E5-81
• Device Catalogue Number: 66-DA-SD, FC1004
• Device Lot Number: 150117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1