APHERESIS PORT
Received Oct 27, 2025 · Event occurred Oct 3, 2025
Report 3006260740-2025-08014 · MDR key 23388761
Device
Generic name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
A710962
Lot number
REEY1202
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO MEDICAL RECORDS WERE PROVIDED FOR REVIEW. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED INFECTION AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. FURTHERMORE, THE CLINICAL CONDITIONS ALLEGED IN THE COMPLAINT CANNOT BE CONFIRMED. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. 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.
Description of Event or Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT WAS DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.