BD POSIFLUSH
Received Dec 11, 2025 · Event occurred Nov 14, 2025
Report 1911916-2025-00788 · MDR key 23778263
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
306547
Lot number
5238064
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BD SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #306547 LOT #5238064. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER SAID BLACK LIKE SUBSTANCE ON AT THE TIP/LUER LOCK AREA OF SYRINGE: LOT # 5238064 BD POSIFLUSH 306547.
Additional Manufacturer Narrative
E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. IT WAS REPORTED THERE IS A BLACK-LIKE SUBSTANCE ON THE LUER LOCK AREA OF THE SYRINGE. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 306547 AND LOT NUMBER 5238064. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY. COMPLAINTS RELATED TO THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE MONITORED AND ANALYZED FOR EMERGING TRENDS BY OUR QUALITY TEAM.