ENCOR VACUUM CANISTER
Report
- Report Number
- 2020394-2025-01519
- Event Type
- Malfunction
- Date Received
- September 19, 2025
- Date of Event
- August 28, 2025
- Report Date
- October 22, 2025
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- KNW
- UDI-DI
- 10801741086691
- PMA / PMN Number
- K013641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- 003
Narratives
H11: ADDITIONAL INFORMATION WAS RECEIVED AND THERE IS NO ALLEGED DEFICIENCY OR MALFUNCTION WITH THE PRODUCT. THIS REPORT IS NO LONGER BEING CONSIDERED A COMPLAINT FILE AND DETERMINED TO BE NO LONGER REPORTABLE. SINCE AN INITIAL MDR WAS SUBMITTED, THEREFORE, THE FILE WILL REMAIN ASSESSED AS A MALFUNCTION. D2B (GEI; KNW), G3. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. D2B (GEI; KNW). SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCORE INSTRUMENT. DURING THIS PROCEDURE, THE ENCORE CODES WERE FOUND IN BOXES THAT EMITTED A FOUL ODOR, CAUSING ILLNESS AMONG THE LABELING STAFF, INCLUDING SYMPTOMS SUCH AS NAUSEA, GENERAL MALAISE, AND DIARRHEA. HOWEVER, THERE WERE NO REPORTED INJURIES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1983255 | ENCOR VACUUM CANISTER | BIOPSY INSTRUMENT | KNW | BARD PERIPHERAL VASCULAR, INC. | VTKS0001 | 10801741086691 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |