PINNACLE® 2112342Recalls & reported problems
B. Braun Medical Inc. · PINNACLE® 9-Lead Vented Transfer Set · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046964200311), received between Aug 25, 2017 and Feb 10, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Improper Flow or Infusion3
- Material Discolored2
- Reflux within Device2
- Component Misassembled1
- Device Markings/Labelling Problem1
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Patient Involvement4
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2023Material Discolored; Reflux within Device; Material Discolored; Reflux within Device
AS REPORTED BY THE USER FACILITY: "TPN BAGS THAT SHOULD HAVE REMAINED CLEAR WERE CLOUDY WHICH LED US TO BELIEVE THAT THERE MAY BE BACKFLOW OF LIPIDS." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16350511 ↗MalfunctionFeb 10, 2023Material Discolored; Reflux within Device; Material Discolored; Reflux within Device
AS REPORTED BY THE USER FACILITY: "TPN BAGS THAT SHOULD HAVE REMAINED CLEAR WERE CLOUDY WHICH LED US TO BELIEVE THAT THERE MAY BE BACKFLOW OF LIPIDS." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16350486 ↗MalfunctionNov 23, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE LEAD LABEL WAS INCORRECT. AS REPORTED BY THE CUSTOMER, "THE DEVICE HAS TWO SAME NUMBERS." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15853336 ↗MalfunctionJan 16, 2019Component Misassembled; Component Misassembled
AS REPORTED BY USER FACILITY: TRANSFER SETS ARE LABELED BACKWARDS, FROM LEFT TO RIGHT THE LEADS ARE LABELED 9, 8, 7, 6, 5, 4, 3, 2, 1, INSTEAD OF 1, 2, 3, 4, 5, 6, 7, 8, 9. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8254201 ↗MalfunctionJun 25, 2018Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY USER FACILITY: TRANSFER SET IS LEAKING LIPIDS INTO THE OTHER LINES. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7635171 ↗MalfunctionJun 4, 2018Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY USER FACILITY: THERE IS BACKFLOW FROM MANIFOLD INTO THE OTHER LEADS. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7567161 ↗MalfunctionJun 4, 2018Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY USER FACILITY: THE DEVICE WAS LEAKING LIPIDS INTO THE OTHER LINES THROUGH THE MANIFOLD THAT THE TUBING WAS CONNECTED TO. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7567160 ↗MalfunctionAug 25, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem
AS REPORTED BY USER FACILITY: THE BARCODE LABELS FOR THE #8 LEAD TUBE AND THE #9 LEAD TUBE WERE SWITCHED. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6820073 ↗
Other Set, i.V. Fluid transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- 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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