MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for SUNMED 9-0212-70 manufactured by .
[142925284]
The device in question was manufactured prior to 2011 and without a returned device or pictures of the physical product the customer complaint cannot be confirmed nor denied. A picture of the pouch was supplied which shows the products part number, lot number, and old sunmed logo. The pouch does not show an expiration date but the current product offering from sunmed has a three (3) year shelf life. The current sunmed product is manufactured by a different supplier and utilizes a different lot number system which allows the investigation to state the device in questions was manufactured prior to 2011. Based on the customer complaint date in (b)(6) 2019 it is feasible to state the device in question is at least eight (8) years old. Given the age of the product, and not being to physically inspect the device in question, this investigation is inconclusive. Trending does not exist for bougies fracturing during use.
Patient Sequence No: 1, Text Type: N, H10
[142925285]
The customer alleges the "bougie shattered". No other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2019-00021 |
| MDR Report Key | 8544627 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-03-29 |
| Date Added to Maude | 2019-04-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNMED |
| Generic Name | INTRODUCER |
| Product Code | BSR |
| Date Received | 2019-04-24 |
| Model Number | 9-0212-70 |
| Lot Number | PRN05-3929 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-24 |