MAGNUM INSTRUMENT
Report
- Report Number
- 2020394-2025-00961
- Event Type
- Malfunction
- Date Received
- July 3, 2025
- Date of Event
- June 5, 2025
- Report Date
- August 19, 2025
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- KNW
- UDI-DI
- 00801741083945
- PMA / PMN Number
- K934371
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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: MANUFACTURING REVIEW: A DHR AND MANUFACTURING REVIEW WAS NOT REQUIRED AS THE EVENT WAS DETERMINED TO BE EXPECTED, AND THE INVESTIGATION DID NOT IDENTIFY ANY MANUFACTURING AND/OR SERVICE-RELATED ISSUES. INVESTIGATION SUMMARY: THE MAGNUM DRIVER SERIAL NUMBER (B)(6) WAS RECEIVED AT THE BIP BIOMEDIZINISCHE INTSTRUMENTE UND PRODUKTE GMBH. THE MAGNUM DRIVER WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE BAD CONDITION. THE DEVICE WAS FUNCTIONALLY TESTED AND FAILED THE TESTS DUE TO DEVICE HAS SOMETIMES PROBLEMS TO HOLD THE SLEDS IN PLACE BECAUSE THE DEVICE IS SO DIRTY THAT THE SEQUENCER CAN NOT WORK RIGHT IDENTIFIED DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE INCONCLUSIVE FOR THE REPORTED DEVICE SELF-ACTIVATION ISSUE, AND THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED DEVICE HAS SOMETIMES PROBLEMS TO HOLD THE SLEDS IN PLACE ISSUE. THE ROOT CAUSE CANNOT BE DETERMINED AS THE DEVICE COULD NOT BE TESTED FOR THE REPORTED DEVICE SELF ACTIVATION ISSUE. THE ROOT CAUSE FOR IDENTIFIED DEVICE HAS SOMETIMES PROBLEMS TO HOLD THE SLEDS IN PLACE ISSUE WAS DETERMINED TO BE DIRT IN DEVICE WHICH CAUSE SEQUENCER CANNOT WORK RIGHT IDENTIFIED DURING EVALUATION. LABELING REVIEW: THE LABELING/PACKAGING REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH A LABELING, PACKAGING, OR USE RELATED ISSUE. G3, H6 (DEVICE, COMPONENT, RESULT, CONCLUSION). 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.
IT WAS REPORTED THAT THE MAGNUM DEVICE FIRES WHEN IN FIRST CHARGE AND IT FIRES WELL BUT THE SECOND ONE FIRES BY ITSELF. THERE IS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED, THE DEVICE PRIMED AND LOCKED INTO THE FIRST PRIME POSITION THEN WHEN THEY WERE PRIMING THE SECOND TIME THE DEVICE PRIMED AND LOCKED INTO FULL PRIME POSITION THEN FIRED IMMEDIATELY AFTER IT WAS FULLY PRIMED.
IT WAS REPORTED THAT THE MAGNUM DEVICE FIRES WHEN IN FIRST CHARGE AND IT FIRES WELL BUT THE SECOND ONE FIRES BY ITSELF. THERE IS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED, THE DEVICE PRIMED AND LOCKED INTO THE FIRST PRIME POSITION THEN WHEN THEY WERE PRIMING THE SECOND TIME THE DEVICE PRIMED AND LOCKED INTO FULL PRIME POSITION THEN FIRED IMMEDIATELY AFTER IT WAS FULLY PRIMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1176816 | MAGNUM INSTRUMENT | BIOPSY INSTRUMENT | KNW | BARD PERIPHERAL VASCULAR, INC. | 00801741083945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |