MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-10-29 for WEIGHTRIGHT MERCURY-FREE BOUGIE 1208-52 manufactured by Medovations Inc..
[29922903]
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.
Patient Sequence No: 1, Text Type: N, H10
[29922904]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183446-2015-00001 |
| MDR Report Key | 5189374 |
| Report Source | USER FACILITY |
| Date Received | 2015-10-29 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2015-09-29 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2015-10-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA BOLL |
| Manufacturer Street | 102 E KEEFE AVE |
| Manufacturer City | MILWAUKEE WI 53212 |
| Manufacturer Country | US |
| Manufacturer Postal | 53212 |
| Manufacturer Phone | 4142657620 |
| Manufacturer G1 | MEDOVATIONS INC. |
| Manufacturer Street | 102 E KEEFE AVE |
| Manufacturer City | MILWAUKEE WI 53212 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEIGHTRIGHT MERCURY-FREE BOUGIE |
| Generic Name | BOUGIE, ESOPHAGEAL AND GASTROINTESTINAL |
| Product Code | FAT |
| Date Received | 2015-10-29 |
| Model Number | 1208-52 |
| Catalog Number | 1208-52 |
| Lot Number | 213676 |
| Device Expiration Date | 2015-09-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOVATIONS INC. |
| Manufacturer Address | 102 E KEEFE AVE MILWAUKEE WI 53212 US 53212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-29 |