Irrigation SyringeRecalls & reported problems across all models
C. R. Bard, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of Irrigation Syringe by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between May 2, 2017 and Dec 1, 2021 — classified as 1 injury, 140 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (121 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Irrigation Syringe problems
Device problems
- Device Contamination with Chemical or Other Material121
- Contamination /Decontamination Problem27
- Break8
- Contamination8
- Device Damaged Prior to Use6
- Defective Component4
- Detachment Of Device Component4
- Material Discolored3
Patient problems
- No Known Impact Or Consequence To Patient87
- No Patient Involvement73
- No Consequences Or Impact To Patient28
- No Clinical Signs, Symptoms or Conditions24
- No Information8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Foreign Body In Patient3
Irrigation Syringe models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Irrigation Syringe 0935280SYRINGE, IRRIGATING (NON DENTAL)83 reports
- Irrigation Syringe 0035280SYRINGE, IRRIGATING (NON DENTAL)58 reports
Recent Irrigation Syringe adverse event reports
The 15 most recent reports across all models, 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 18, 2021Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE SUCTION PORT OF THE BULB IRRIGATION SYRINGE WAS BLOCKED BY SOMETHING. SO WATER WAS UNABLE TO BE SUCKED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11844109 ↗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 ↗MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE SYRINGE. PER FOLLOW UP VIA IBC ON 18MAR2021, THE ISSUE WAS FOUND UPON OPENING OF THE PACKAGE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 11604206 ↗MalfunctionFeb 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND IN A STERILIZED PACK BEFORE OPENING THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11362988 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 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