Precision Delivery IV Extension Set, Amber PDV60FARecalls & reported problems
Quest Medical Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00634624922044), received between Jan 6, 2023 and Jul 18, 2024 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak5
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Hypoglycemia1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2024Material Separation; Material Separation
IT WAS REPORTED THAT DURING FLUID DELIVERY PROCEDURE, THE DEVICE ALLEGEDLY MALFUNCTIONED AT THE FILTER AND SUBSEQUENTLY THE PATIENT HAD TO RECEIVE MEDICAL INTERVENTION DUE TO FURTHER DETERIORATION OF HEALTH. THE FLUID DELIVERY PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: Hypoglycemia
MAUDE report 19779024 ↗MalfunctionJan 18, 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 LIPID LINE LEAK AT THE JUNCTION, JUST PRIOR TO THE FILTER. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16199458 ↗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 16118206 ↗MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) 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 16118204 ↗MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) 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 16118203 ↗MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED TO QUEST MEDICAL BY (B)(4) 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 16118202 ↗
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, ClassifiedPrecision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Other Set, Administration, Intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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