PORT ACCESS INSERT OUTPNT
Received Aug 7, 2025 · Event occurred Jul 9, 2025
Report 1417592-2025-00374 · MDR key 22743228
Device
Generic name
Port Access Insert Outpnt
Manufacturer
Medline Industries, LpCatalog number
CVI5190A
Lot number
25ABG414
Product problems
- Break
- Break
Patient
68 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2025 "THE SYRINGE WING WAS CRACKED AND WHEN THE NURSE TRIED TO FLUSH THE PORT, SHE WASN'T ABLE TO FLUSH MORE WITHOUT FEELING LIKE THE SYRINGE WAS GOING TO BREAK" AND ANOTHER SALINE SYRINGE WAS RETRIEVED.
Additional Manufacturer Narrative
IT WAS REPORTED THAT ON (B)(6) 2025 "THE SYRINGE WING WAS CRACKED AND WHEN THE NURSE TRIED TO FLUSH THE PORT, SHE WASN'T ABLE TO FLUSH MORE WITHOUT FEELING LIKE THE SYRINGE WAS GOING TO BREAK" AND ANOTHER SALINE SYRINGE WAS RETRIEVED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.