MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-15 for BOVIE MEDICAL AA01 manufactured by Bovie Medical.
[50620673]
Distributor received (1) one unit of the aa01 with lot # 2016-01-01, sterile lot # 0116a with unsealed pouch. The returned product was inspected and it was confirmed that the pouched unit was unsealed. It was confirmed that the pouches never went through the sealer as there was no evidence of marks in the seal. No additional complaints for unsealed pouches have been received for aa01 with lot # 2016-01-01 sterile lot # 0116a. This the first instance of this event for this product and product family. Review of the batch record showed no non-conformances noted during pouching, packaging or qc inspection processes. Our investigation suggests this to be an isolated event. The investigation concluded that the aa01 pouch was not sealed due to improper workflow and handling by the packaging operator. During the investigation, it was observed that improper handling provided the potential opportunity for an unsealed unit to be placed into the container with sealed pouches. Although qc random sampling inspection for sealed pouches is performed on every container, it did not detect this single unit. Employees were made aware of the event, and the pouch sealing employees were instructed to assure adequate handling and separation of unsealed pouches. In addition, the sealing process will be provided with a mechanism to collect sealed pouches without the assistance of the operator. Also, a new reconciliation process will be implemented to assure that unsealed and sealed pouches quantities are verified prior to subsequent boxing operations and product release.
Patient Sequence No: 1, Text Type: N, H10
[50620674]
Distributor received (1) one unit with unsealed pouch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007593903-2016-00002 |
| MDR Report Key | 5797724 |
| Date Received | 2016-07-15 |
| Date of Report | 2016-03-22 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2016-02-23 |
| Device Manufacturer Date | 2016-01-16 |
| Date Added to Maude | 2016-07-15 |
| 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 | MS JULIE MCDONALD |
| Manufacturer Street | 5115 ULMERTON ROAD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal | 337604004 |
| Manufacturer Phone | 7278038554 |
| Manufacturer G1 | BOVIE MEDICAL |
| Manufacturer Street | 5115 ULMERTON ROAD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 337604004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BOVIE MEDICAL |
| Generic Name | CAUTERY HIGH TEMP FINE TIP |
| Product Code | HQP |
| Date Received | 2016-07-15 |
| Returned To Mfg | 2016-02-29 |
| Catalog Number | AA01 |
| Lot Number | 0116A |
| Device Expiration Date | 2020-01-01 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOVIE MEDICAL |
| Manufacturer Address | 5115 ULMERTON ROAD CLEARWATER FL 337604004 US 337604004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-15 |