Port Access Needle 0141915Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc Max 19G x 1.5 inch · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741047428), received between Dec 18, 2018 and Jan 31, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
1 FDA recall record name this device's identifier.
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
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2670-2020 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Device Fell1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2019Material Separation; Detachment of Device or Device Component
IT WAS REPORTED VIA MEDWATCH REPORT THAT THE "NURSE WAS PREPARING TO ACCESS A PORT WHEN THE POWER INJECTION INFUSION SET FELL APART. THE TUBING CAME OFF AT THE NEEDLE SET. THE NURSE HAD PRIMED THE LINE WITH NORMAL SALINE AND WAS GOING TO ACCESS THE PORT. AS SHE PICKED UP THE PORT NEEDLE AND WAS ABOUT TO ACCESS THE PATIENT, THE ENTIRE TUBING FELL INTO X3 PIECES (NEEDLE, TUBING, AND CLAMP). THE NEEDLE WAS NEVER INSERTED INTO THE PATIENT."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8295268 ↗MalfunctionDec 18, 2018Detachment of Device or Device Component; Device Fell
NURSE WAS PREPARING TO ACCESS A PORT WHEN THE POWER INJECTION INFUSION SET FELL APART. THE TUBING CAME OFF AT THE NEEDLE SET. THE NURSE HAD PRIMED THE LINE WITH NORMAL SALINE AND WAS GOING TO ACCESS THE PORT. AS SHE PICKED UP THE PORT NEEDLE AND WAS ABOUT TO ACCESS THE PATIENT, THE ENTIRE TUBING FELL INTO X3 PIECES (NEEDLE, TUBING AND CLAMP). THE NEEDLE WAS NEVER INSERTED INTO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8174510 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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