Irrigation Syringe 0935280Recalls & reported problems
C. R. Bard, Inc. · Davol Irrigation Syringe Bulb Type, 50cc · Class 1
All models of Irrigation Syringe (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Davol bulb-type irrigation syringe is a rubber-bulb syringe used for flushing. The 83 reports, none from the last 12 months, mostly describe contamination found inside the syringe before use — things like hairs, debris, dark specks, stains, moisture, and an oily residue. There were no deaths, 1 injury, 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
- 83
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 10801741051378), received between May 11, 2017 and Dec 1, 2021 — classified as 1 injury, 82 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (71 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material71
- Contamination /Decontamination Problem15
- Break6
- Device Damaged Prior to Use6
- Contamination5
- Defective Component4
- Material Fragmentation3
- Detachment Of Device Component2
Patient problems
- No Known Impact Or Consequence To Patient53
- No Patient Involvement36
- No Consequences Or Impact To Patient19
- No Clinical Signs, Symptoms or Conditions15
- No Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Foreign Body In Patient3
Recent adverse event reports
The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE ASEPTO BULB SYRINGE HAD SOME DEBRIS ON IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12908510 ↗MalfunctionSep 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BULB SYRINGE WAS FOUND TO HAVE A HAIR IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12541068 ↗MalfunctionJul 30, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE PACK WITH THE BULB SYRINGE APPEARED AS CONDENSATION BUT HAD A SLICK AND OILY FEEL FROM THE BREAST TRAY. PER FOLLOW UP VIA EMAIL ON (B)(6) 2021, THE CUSTOMER STATED THAT THE OILY SUBSTANCE WAS FOUND INSIDE THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12253106 ↗MalfunctionJul 15, 2021Moisture Damage; Moisture Damage
IT WAS REPORTED THAT THERE WAS MOISTURE IN THE BULB SYRINGE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12174100 ↗MalfunctionJul 15, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS HAIR FOUND IN THE SYRINGE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12173456 ↗MalfunctionJul 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS A BLACK HAIR FOUND INSIDE THE BULB SYRINGE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 12170403 ↗MalfunctionJul 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BULB SYRINGE HAD A BLACK STAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12106921 ↗MalfunctionJun 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE ASEPTO BULB SYRINGE AND KIDNEY BASIN HAD BLACK SPECS IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12079161 ↗MalfunctionJun 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE GNAT WAS INSIDE AN ASEPTO BULBE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11942438 ↗MalfunctionMay 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BLACK HAIR WAS FOUND IN BETWEEN BULB AND ASEPTO SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11885468 ↗MalfunctionMay 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BARD ASEPTO SYRINGE WITHIN THE PACK HAD A HAIR LODGED INSIDE OF IT. PER CUSTOMER VIA EMAIL ON 10MAY2021, CUSTOMER STATED THAT THE PRODUCT WAS NEVER USED ON A PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 14MAY2021, STATED THAT THE HAIR WAS LODGED INSIDE OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824526 ↗MalfunctionApr 27, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A SHORT STRING OR HAIR WAS FOUND INSIDE THE BULB SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11732274 ↗MalfunctionFeb 18, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE INSECT WAS FOUND INSIDE THE ASEPTO SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11345972 ↗MalfunctionFeb 9, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE SYRINGE APPEARED TO HAVE SOME FLUID IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11305453 ↗MalfunctionJan 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE SYRINGE APPEARED TO HAVE FLUID IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11230619 ↗MalfunctionJan 15, 2021Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS HAIR INSIDE OF THE ASEPTO SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11177939 ↗MalfunctionDec 5, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE HAIR STUCK TO THE ASEPTO SYRINGE. PER THE CUSTOMER THE HAIR WAS STUCK IN THE SYRINGE HOWEVER IT DID NOT SPECIFY WHETHER IT WAS INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10951871 ↗MalfunctionOct 23, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT LONG HAIR WAS FOUND IN THE ASEPTO SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 10728385 ↗MalfunctionAug 24, 2020Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS A HAIR ON THE SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10445787 ↗MalfunctionApr 13, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT HAIR WAS FOUND IN THE BULB WHILE THE SYRINGE WAS STILL IN THE PACKAGE. THE ISSUE WAS NOTED PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 9954582 ↗MalfunctionApr 2, 2020Device Damaged Prior to Use; Defective Component; Device Damaged Prior to Use
IT WAS REPORTED THAT THE BULB WAS DEFECTIVE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9917890 ↗MalfunctionApr 2, 2020Device Damaged Prior to Use; Output Problem; Device Damaged Prior to Use
IT WAS REPORTED THAT THE BULB WAS FAULTY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9917889 ↗MalfunctionApr 2, 2020Device Damaged Prior to Use; Output Problem; Device Damaged Prior to Use
IT WAS REPORTED THAT THE BULB WAS FAULTY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9917055 ↗MalfunctionApr 2, 2020Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE CUSTOMER STATED THAT THERE WAS SOMETHING STUCK INSIDE OF THE SYRINGE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9917046 ↗MalfunctionApr 2, 2020Device Damaged Prior to Use; Defective Component; Device Damaged Prior to Use
IT WAS REPORTED THAT THE BULB WAS FAULTY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9916945 ↗
Other SYRINGE, IRRIGATING (NON DENTAL) devices
- N/A 309620Becton, Dickinson And Company · SYRINGE, IRRIGATING (NON DENTAL)73 reports
- Irrigation Syringe 0035280C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)58 reports
- MEDLINE DYND20125Medline Industries, Inc. · SYRINGE, IRRIGATING (NON DENTAL)1 recall3 reports
- Rapid Refill M00566000Boston Scientific Corporation · SYRINGE, IRRIGATING (NON DENTAL)1 recall0 reports
- NICO Fluid System NN-8015Nico Corporation · Syringe, Irrigating (Non Dental)1 recall0 reports
- MEDLINE DYND20302Medline Industries, Inc. · SYRINGE, IRRIGATING (NON DENTAL)15 reports
- Piston Irrigation Tray 750307C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)15 reports
- Toomey Syringe 0038460C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)9 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.
How reports and recalls are matched · Editorial policy · Report an error on this page