N/A 300866Recalls & reported problems
Becton Dickinson & Company Ltd · SYRINGE 50ML E/T · Class 2
Quick summary
This is a BD eccentric Luer slip-tip syringe. The 36 reports mostly describe physical problems with the syringe itself: leaking or splashing, cracked barrels and plungers, a stopper that peeled or distorted inside the barrel, plus packaging and labeling mix-ups such as boxes marked for a different size. No deaths or injuries are reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00382903008667), received between Nov 27, 2017 and Aug 31, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (9 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash9
- Break6
- Material Deformation6
- Device Markings/Labelling Problem3
- Packaging Problem3
- Device Contamination with Chemical or Other Material2
- Contamination1
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient8
- No Patient Involvement5
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533759 ↗MalfunctionFeb 3, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT 3 BD¿ ECCENTRIC LUER SLIP TIP SYRINGE HAD THE INCORRECT LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM TETUM TO ENGLISH: (B)(4) SHOULD BE FOR SYRINGE 60ML ET, BUT THE LABEL IN PHYSICAL STOCK SHOWING 50ML LUER SYRINGE, PLEASE REFER TO BELOW PHOTOS SHARED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16288536 ↗MalfunctionDec 20, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BD¿ ECCENTRIC LUER SLIP TIP SYRINGE STOPPER PEELED OFF WITHIN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM MANDARIN CHINESE TO ENGLISH: THERE SEEMS A PIECE OF STOPPER PEELED OFF WITHIN THE BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16018267 ↗MalfunctionOct 10, 2022Break; Break
IT WAS REPORTED THAT 3 BD PLASTIPAK¿ SYRINGES' BARRELS WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN BARREL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15571818 ↗MalfunctionJul 14, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN BARREL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15019710 ↗MalfunctionApr 18, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE THE STOPPER WAS DISTORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14136405 ↗MalfunctionMar 20, 2022Break; Break
IT WAS REPORTED WHILE USING BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK THE PLUNGER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13830020 ↗MalfunctionMar 1, 2022Defective Device; Defective Device
IT WAS REPORTED WHEN USING THE BD SYRINGE 60ML E/T, THE DEVICE EXPERIENCED A BROKEN BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BROKEN BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636576 ↗MalfunctionFeb 22, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BARREL WAS BROKEN ON THE BD¿ ECCENTRIC LUER SLIP TIP SYRINGE. THIS EVENT OCCURRED 2 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13577913 ↗MalfunctionFeb 18, 2022Material Deformation; Material Deformation
IT WAS REPORTED WHILE USING BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE A BARREL WAS FOUND TO BE BROKEN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13559919 ↗MalfunctionFeb 9, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE FOREIGN MATTER WAS FOUND IN THE FLUID PATH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A SYRINGE B+D 50/60ML LUER WAS SORTED OUT BECAUSE A SMALL GRAY-BROWN PARTICLE WAS DETECTED IN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500803 ↗MalfunctionFeb 2, 2022Break; Break
IT WAS REPORTED WHILE USING 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE A PLUNGER WAS FOUND TO BE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13429358 ↗MalfunctionJan 28, 2022Material Deformation; Material Deformation
IT WAS REPORTED WHEN USING THE BD SYRINGE 60ML E/T, THE DEVICE EXPERIENCED A DEFECTIVE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DISTORTED STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13387301 ↗MalfunctionJan 24, 2022Material Deformation; Material Deformation
IT WAS REPORTED WHILE USING 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE THE STOPPER WAS FOUND TO BE DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13337830 ↗MalfunctionJan 21, 2022Break; Break
IT WAS REPORTED THAT BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE HAD A DAMAGED TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN BARREL".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13319658 ↗MalfunctionDec 16, 2021Break; Break
IT WAS REPORTED WHEN USING THE BD SYRINGE 60ML DEVICE EXPERIENCED A DAMAGED / BROKEN PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PLUNGER FLANGE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13023472 ↗MalfunctionNov 16, 2021Material Separation; Material Separation
IT WAS REPORTED WHEN USING THE BD SYRINGE 60ML E/T , THE DEVICE EXPERIENCED STOPPER SEPARATION FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DISCONNECT BETWEEN STOPPER AND PLUNGER ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12820005 ↗MalfunctionSep 3, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE SYRINGE 60ML E/T THE STOPPER WAS DEFECTIVE/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE STOPPER IS DEFORMED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12425347 ↗MalfunctionAug 24, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT THE SYRINGE 60ML E/T PLUNGER ROD BROKE AFTER DRAWING UP MEDICATION. ADDITIONALLY, ANOTHER SYRINGE LEAKED PAST THE STOPPER WHEN DRAWING UP MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE WALL BREAKS AFTER DRUG WITHDRAWAL. LEAKAGE FROM THE SYRINGE AFTER THE MEDICINE IS DRAWN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12363453 ↗MalfunctionAug 20, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED THAT 50 50 ML BD PLASTIPAK¿ LUER-SLIP SYRINGES EXPERIENCED DAMAGED PACKAGING WHERE THE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OPERATING THEATRE HAVE IDENTIFIED SOME UNUSUAL PACKAGING IMPRINTS ON THE BD 20ML & 30ML SYRINGES TODAY WHICH WE HAVE SOME SIGNIFICANT CONCERNS OF STERILITY OF THE SYRINGE PACKET. WE HAVE NOTED THAT THE PACKETS ALL HAVE THE SAME INDENTATIONS ON THE CLEAR WRAP AND WHEN YOU SQUEEZE THE PACKET AND PACKET THEN INFLATES WHICH SUGGESTS THERE MAYBE HOLES IN THE PACKETS, OR COULD SIMPLY SUGGEST THE AIR IS SHIFTING THROUGH THE PLUNGER BACKWARDS AND FORWARDS. WE HAVE REMOVED ALL 30 ML SYRINGES AND AFFECTED 20ML SYRINGES UNTIL WE CAN GET SOME ADVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351639 ↗MalfunctionJun 2, 2021Fungus in Device Environment; Fungus in Device Environment
IT WAS REPORTED THAT A SYRINGE 60ML E/T HAD MOLD PRESENCE BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "CONTAMINANT THAT LOOKS LIKE PIECE OF FLUFF OR MOULD FOUND IN STERILE SYRINGE. NOTICED BY OPERATOR AND DISCARDED BEFORE USE. NO HARM CAUSED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11925075 ↗MalfunctionMay 21, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT SYRINGE 60ML E/T HAD A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "50 CC EMPTY NEEDLE BODY SPLITS A PUNCH ARC".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11863143 ↗MalfunctionJan 20, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SYRINGE 60ML E/T HAD THE TIP DAMAGED AT AN UNSPECIFIED TIME. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE TIP BENT".
Patient problems: No Patient Involvement
MAUDE report 11202808 ↗MalfunctionDec 5, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT SYRINGE 60ML E/T WAS BENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEND STRAIGHT.
Patient problems: No Patient Involvement
MAUDE report 10954450 ↗MalfunctionDec 3, 2020Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT 60 50 ML BD PLASTIPAK¿ LUER-SLIP SYRINGES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMUDGING OF THE LINES AND WORDINGS.
Patient problems: No Patient Involvement
MAUDE report 10939118 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.