MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for MALLEABLE DUAL CANNULA TIP 20 GAUGE X 4 INCH LENGTH 800-0202 manufactured by Biomet, Inc..
[139371933]
Our surgical team has used the biomet product ref# 800-0202. This is an applicator tip dual cannula, malleable. The applicator comes with a lot number and date printed on the package, and four additional peel-off labels for additional reference. However, the date code printed on the package and peel-off labels do not match. One package has a date of 2021-09 as the expiration, but the peel-off labels have a date of 2016-09 indicating the product is expired. A second package has a date of 2022-01, but the peel-off has an expiration date of 2017-01 making this appear as expired. The concern is there is not a secure way of telling which date is accurate, putting the patient at risk with potentially expired product. Manufacturer response for applicator tip dual cannula, malleable, applicator tip dual cannula, malleable (per site reporter). Mfg was aware of the issue but did not offer a resolution to the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8435908 |
| MDR Report Key | 8435908 |
| Date Received | 2019-03-20 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-05-01 |
| Report Date | 2017-08-03 |
| Date Reported to FDA | 2017-08-03 |
| Date Reported to Mfgr | 2017-08-14 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | MALLEABLE DUAL CANNULA TIP 20 GAUGE X 4 INCH LENGTH |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2019-03-20 |
| Model Number | 800-0202 |
| Catalog Number | 800-0202 |
| Lot Number | 170250 |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | 56 E BELL DR. WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-20 |