Medline Industries, Inc. CVI5190ARecalls & reported problems
Medline Industries, Inc. · PORT ACCESS INSERT OUTPNT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10198459107283), received between May 23, 2025 and Aug 7, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Break; Break
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22743228 ↗MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025 WHEN THE PORT WAS BEING FLUSHED IT WAS IDENTIFIED THAT THE "SYRINGE WING WAS BROKEN AND RIPPED THE NURSE'S GLOVE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645093 ↗MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025 WHEN THE PORT WAS BEING FLUSHED IT WAS IDENTIFIED THAT THE "SYRINGE WING WAS BROKEN AND RIPPED THE NURSE'S GLOVE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644478 ↗MalfunctionMay 23, 2025Crack; Crack
SYRINGE LEAKED WITHIN KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079083 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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