Precision Delivery IV Extension Set, Amber PDTV05FARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00634624921023), received between Jan 6, 2023 and Sep 29, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K202672); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO QUEST BY (B)(6) MEDICAL CENTER OF AN ALLEGED LEAK WITH PRODUCT CODE PDTV05FA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17846165 ↗
• MalfunctionSep 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(4) WAS RECIEVED FROM THE FDA ON 08/28/2023. THE REPORT STATED THAT AN AMBER INFUSION SET WAS FOUND SNAPPED AND DISCONNECTED FROM THE FILTER, AND THAT BLOOD WAS BACKED UP IN THE BLUE PICC CONNECTION. THE INFUSION PUMP WAS ALSO ALARMING FOR OCCLUSION. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785905 ↗
• MalfunctionSep 6, 2023Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED TO QUEST MEDICAL BY ST. JOSEPH'S HOSPITAL AND MEDICAL CENTER OF AN ALLEGED LEAK WITH PDTV05FA TRIFUSE DELIVERY SETS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695407 ↗
• MalfunctionFeb 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL OF AN ALLEGED ISSUE WITH A PRECISION DELIVERY IV SET. THE REPORT STATED THAT THE SET HAD A LEAK DURING INFUSION AT THE CONNECTION OF THE THREE LINES. THE LINE WAS CHANGED OUT UNDER STERILE TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438918 ↗
• MalfunctionFeb 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL OF AN ALLEGED ISSUE WITH A PRECISION DELIVERY IV SET. THE REPORT STATED THAT THE SET HAD A LEAK DURING INFUSION AT THE TPN FILTER. THE LINE WAS CHANGED OUT UNDER STERILE TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438904 ↗
• MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) HOSPITAL AND MEDICAL CENTER OF AN ALLEGED LEAKING IV ADMINISTRATION SET, REQUIRING THE SET TO BE CHANGED OUT. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118205 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K202672. One submission often covers many models, so check the product and lot details in each record.

• Z-1100-2023 · Dec 23, 2022 · Open, Classified
  Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2