MAUDE Adverse Event Report: MEDOVATIONS INC. WEIGHTRIGHT MERCURY-FREE BOUGIE; BOUGIE, ESOPHAGEAL AND GASTROINTESTINAL

Model Number 1208-52

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

The device did not malfunction in this reported situation.The customer reports that the device has the lot number and expiration date on the device, written in marker, and that the device is at or near the date of expiration.This is not a device malfunction since the lot number and expiration date are written onto the device during our standard documented manufacturing processes with a black sharpie permanent marker on the day the device is shipped.Esophageal dilators (bougies) are reusable devices with a 3 year expiration date and are manufactured to customer order.Final assembly is completed after receiving the customer order.To maintain manufacturing efficiencies, a sharpie permanent marker is used to write in the manufacturer lot number and expiration date within a designated space on each device during that final assembly.This manufacturing process has been successfully used for over 15 years.All bougies are 100% inspected for correct lot number and expiration date before shipping.Inspection records are maintained in the device history record for each lot number.Device history records are maintained for a minimum of 10 years.The esophageal dilators (bougies) are reusable devices and the 3 year expiration date in use is an industry standard for these types of devices and had been used by medovations for over 15 years.Medovations has performed testing to show that the sharpie permanent marker remains legible throughout a 3 year lifetime of standard use and reprocessing.Additionally, risks from this practice have been evaluated and determined to be negligible.In addition to our testing that shows the sharpie permanent marker remains legible throughout the device's anticipated life (risk control, inherent safe design), risk management also covered scenarios where there may be excessive wear and tear.All devices include instructions for use with a warning for the user to inspect for fitness for use before each use, including an inspection that the three (3) year expiration date has not been exceeded (risk control, information for safety).These instructions for use are also available on medovations' website (risk control, information for safety).Medovations also notifies each customer of expiring bougies by letter a few months before they expire as a final risk mitigation practice in place for any remaining scenarios (risk control, information for safety).Medovations examination of our manufacturing processes, quality controls, and device history records have concluded that there was no device malfunction in this reported situation.

Event Description

Event description from user: when the nurse and tech went to the shelf they noticed the bougie tubes had a lot number and date that seemed to be put on the tubes with a marker instead of being stamped on.Hard to tell.Items were expiring and rep told the operating room staff not to use them since they were expiring.What was the original intended procedure? none.Device usage problem: not applicable.

• Brand Name: WEIGHTRIGHT MERCURY-FREE BOUGIE
• Type of Device: BOUGIE, ESOPHAGEAL AND GASTROINTESTINAL
• Manufacturer (Section D): MEDOVATIONS INC.; 102 e keefe ave; milwaukee WI 53212
• Manufacturer (Section G): MEDOVATIONS INC.; 102 e keefe ave; milwaukee WI 53212
• Manufacturer Contact: laura boll ; 102 e keefe ave; milwaukee, WI 53212 ; 4142657620
• MDR Report Key: 5189374
• MDR Text Key: 29922903
• Report Number: 2183446-2015-00001
• Device Sequence Number: 1
• Product Code: FAT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2015

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: No Information
• Device Expiration Date: 09/01/2015
• Device Model Number: 1208-52
• Device Catalogue Number: 1208-52
• Device Lot Number: 213676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1