MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for BARD-PARKER STAINLESS STEEL BLADE #10 manufactured by Aspen Surgical, Inc..
[141953595]
The 10 blade in it's bard-parker original packaging is contained in one of our surgical packs. When the scrub nurse began peeling open the outer metal packaging, the inner paper packaging over blade did not peel back on either side to expose the blade. Blade with packaging passed off sterile field and additional bard parker 10 blade obtained from supply cart and opened on sterile field. Staff reported the same event on prior procedure but the scrub used heavy scissors to cut blade out of packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8514336 |
| MDR Report Key | 8514336 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-03-25 |
| Report Date | 2019-03-26 |
| Date Reported to FDA | 2019-03-26 |
| Date Reported to Mfgr | 2019-04-15 |
| Date Added to Maude | 2019-04-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BARD-PARKER STAINLESS STEEL BLADE #10 |
| Generic Name | BLADE, SCALPEL |
| Product Code | GES |
| Date Received | 2019-04-15 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL, INC. |
| Manufacturer Address | 6945 SOUTHBELT DRIVE SE CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-15 |