0.50MCI 1251 BRACHYSOURCE
Report
- Report Number
- 1018233-2021-02922
- Event Type
- Malfunction
- Date Received
- May 20, 2021
- Date of Event
- April 22, 2021
- Report Date
- February 2, 2022
- Manufacturer
- BARD BRACHYTHERAPY, INC. -1424526
- Product Code
- KXK
- PMA / PMN Number
- K093663
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H10: THE INITIAL MDR WAS INADVERTENTLY SUBMITTED WITH A G3 DATE OF 04-26-2021. THE CORRECT G3 DATE IS 04-23-2021. H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER AND THIS LOT MET ALL RELEASE CRITERIA. THE MANUFACTURING REVIEW DID NOT INDICATE ANY POSSIBLE MANUFACTURING ISSUE THAT COULD BE RELATED TO THE REPORTED EVENT. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. THE INFORMATION FOR USE WAS REVIEWED. THERE IS A CAUTION STATEMENT, WHICH STATES "IF ANY RADIOACTIVE MATERIAL CANNOT BE ACCOUNTED FOR, THE LOSS MUST BE REPORTED TO THE APPROPRIATE LICENSING AGENCY." H10: (EXPIRY DATE: 09/2021). H11: 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. H3 OTHER TEXT: DEVICE NOT RETURNED.
H10: THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE NO LONGER REPORTABLE. SINCE AN INITIAL MDR WAS SUBMITTED, THEREFORE, THE FILE WILL REMAIN ASSESSED AS A MALFUNCTION. H10: D4 (EXPIRY DATE: 09/2021). H11: 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. H3 OTHER TEXT : DEVICE NOT RETURNED.
IT WAS REPORTED THAT DURING A PROCEDURE, ONE GRAIN OF THE DEVICE WAS ALLEGEDLY FOUND TO BE MISSING FROM THE PARCEL. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING A PROCEDURE, ONE GRAIN OF THE DEVICE WAS ALLEGEDLY FOUND TO BE MISSING FROM THE PARCEL. THERE WAS NO REPORTED PATIENT INJURY.
MANUFACTURING REVIEW: THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER AND THIS LOT MEETS ALL RELEASE CRITERIA. THE MANUFACTURING REVIEW DID NOT INDICATE ANY POSSIBLE MANUFACTURING ISSUE THAT COULD BE RELATED TO THE REPORTED EVENT. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS INCONCLUSIVE, AND THE ROOT CAUSE IS UNDETERMINED. LABELING REVIEW: LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THERE IS A CAUTION STATEMENT, WHICH STATES "IF ANY RADIOACTIVE MATERIAL CANNOT BE ACCOUNTED FOR, THE LOSS MUST BE REPORTED TO THE APPROPRIATE LICENSING AGENCY." (EXPIRY DATE: 09/2021).
IT WAS REPORTED THAT DURING A PROCEDURE, ONE GRAIN OF THE DEVICE WAS ALLEGEDLY FOUND TO BE MISSING FROM THE PARCEL. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754754 | 0.50MCI 1251 BRACHYSOURCE | BRACHYTHERAPY EQUIPMENT & ACCESSORIES | KXK | BARD BRACHYTHERAPY, INC. -1424526 | BBFQ0078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |