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Bard Poly Midline CK000495ARecalls & reported problems

Bard Access Systems, Inc. · Catheter Placement Kit · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741121609), received between Aug 26, 2020 and Apr 22, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 21, 2026Open, Classified

    Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

    Z-2656-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Difficult or Delayed Separation1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • Pain1
  • Thrombosis/Thrombus1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 22, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

    IT WAS REPORTED "INTRODUCER DIDN'T BREAK COMPLETELY AND HAD TO DO GUIDEWIRE EXCHANGE. POSSIBLE LOSS OF VESSEL AND PATIENT WITH VERY LIMITED VENOUS ACCESS."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14188456 ↗
  • InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED VIA MS&S "CALLER STATES A FEW WEEKS AGO HE HAD HIS MIDLINE TAKEN OUT. HE STATES HE NOW FEELS PAIN AND TENDERNESS A FEW INCHES FROM WHERE THE PORT WAS INSERTED. CALLER ASKING IF HE SHOULD CONTACT HIS DOCTOR ABOUT THIS. ALSO WHAT COULD BE CAUSING THIS ISSUE." MS&S RESPONSE "EXPLAINED THAT HE SHOULD CONTACT HIS PHYSICIAN ABOUT THIS PAIN IN HIS ARM. EXPLAINED THAT SOME MEDICATIONS CAN IRRITATE THE VESSELS OF THE UPPER ARM WHEN THEY ARE GIVEN VIA A MIDLINE. EXPLAINED THAT THIS IRRITATION CAN CAUSE RESIDUAL INFLAMMATION IN THE VEIN. IT COULD ALSO BE SOMETHING MORE SERIOUS LIKE AN INFECTION OR BLOOD CLOT. THE ONLY WAY TO KNOW FOR SURE IS TO HAVE IT EVALUATED FURTHER BY HIS PHYSICIAN." ADDITIONAL INFORMATION RECEIVED 03/22/2021: CONCOMITANT THERAPY: "SAW DR. ON (B)(6), VEIN HARD AND SORE, DIAGNOSED A BLOOD CLOT, PRESCRIBED 15 MINUTE HEAT THERAPY THREE TIMES A DAY, CONTACT HIM IF WORSE, REPORT CONDITION IN 5 DAYS."

    Patient problems: Pain; Thrombosis/Thrombus

    MAUDE report 11655460 ↗
  • MalfunctionAug 26, 2020Material Deformation; Material Deformation

    IT WAS REPORTED THE MICROINTRODUCER FOLDED (FISH MOUTHED) WHEN TRYING TO INSERT IT. IT WAS STATED THE USER HAD TO TRIM THE MICROINTRODUCER AND REINSERT NON-TAPERED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10457518 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

All Catheter,intravascular,therapeutic,long-term greater than 30 days devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.