MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-11 for RETRACTABLE SAFETY SCALPEL D4511A manufactured by Deroyal Industries, Inc..
[33960344]
Root cause analysis: the reported issue has been determined to be a random event. The defective scalpel was not returned for evaluation. It is unknown whether the issue occurred due to pre-activation of the scalpel blade. Corrective action and/or systemic correction action taken: due to the investigation and root cause determination, a corrective action has not been taken. Investigation summary: an internal complaint (call (b)(4)) was received indicating that an employee was stuck in the finger by a scalpel blade (part number (b)(4)) upon attempting to remove the device from the packaging. A sample of the defective device was not returned to deroyal for evaluation. The quality control complaint specialist reviewed the routing instructions for part number (b)(4) about the device packaging. The routing instructions state the following: "assure the blade is completely retracted prior to packaging. Place 100 each scalpels in a double polybag. Make sure the scalpels are all turned in the same direction. Twist tie and poly liners shall be closed as firmly around scalpels as possible. Place two polybags with 100 each scalpels in the shipper case with sharp end toward each end of the box. Place one each insert per case. Place outer carton label on outer box. " by packaging the product in the above mentioned manner, the devices can be removed from the shipping case with the blades facing away from the end user. (b)(4). Preventive action: due to the investigation and root cause determination, a preventive action has not been taken. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[33960345]
Cardinal personnel was ready to open a bag containing part (b)(4). The employee was stuck in the finger by a blade that was sticking out of the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004605321-2015-00017 |
| MDR Report Key | 5291116 |
| Date Received | 2015-12-11 |
| Date of Report | 2015-12-11 |
| Date of Event | 2015-11-12 |
| Date Mfgr Received | 2015-11-12 |
| Date Added to Maude | 2015-12-11 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | KM 7, AUTOPISTA JOAQUIN BALAGU PISANO FREE ZONE, BUILDING 18 |
| Manufacturer City | SANTIAGO, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RETRACTABLE SAFETY SCALPEL |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2015-12-11 |
| Catalog Number | D4511A |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | KM 7, AUTOPISTA JOAQUIN BALAGU PISANO FREE ZONE, BUILDING 49 SANTIAGO, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-11 |