Irrigation Syringe 0035280Recalls & reported problems
C. R. Bard, Inc. · Irrigation Syringe, Bulb Type, 50cc · Class 1
All models of Irrigation Syringe (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bard50cc bulb irrigation syringe is used to flush or suction fluid during procedures. Its 58 reports mostly describe dirt, fibers, or other foreign material found inside the syringe or its sealed package, sometimes blocking the suction port so fluid could not be drawn up, along with discoloration and general contamination concerns. None of the reports describe a death or an injury. 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
- 58
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00801741049255), received between May 2, 2017 and May 18, 2021 — classified as 58 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (50 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 16, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material50
- Contamination /Decontamination Problem12
- Contamination3
- Appropriate Device Problem Term/Code Not Available2
- Break2
- Detachment Of Device Component2
- Manufacturing, Packaging or Shipping Problem2
- Material Discolored2
Patient problems
- No Patient Involvement37
- No Known Impact Or Consequence To Patient34
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient9
- No Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionFeb 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A GREEN FOREIGN MATERIAL WAS FOUND IN THE SYRINGE BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11279776 ↗MalfunctionDec 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A DIRT WAS FOUND AFTER OPENING THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11044439 ↗MalfunctionDec 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SEVERAL FOREIGN MATERIALS WERE FOUND INSIDE THE SYRINGE. PER FOLLOW UP WITH THE IBC VIA EMAIL ON (B)(6) 2020, IT WAS UNKNOWN WHERE THE FOREIGN MATERIAL WAS FOUND EXACTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10955797 ↗MalfunctionDec 5, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND PRIOR TO OPENING A PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10951624 ↗MalfunctionDec 5, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT UPON OPENING A PACKAGE THE CUSTOMER FOUND A FOREIGN MATERIAL INSIDE THE PACKAGE. PER FOLLOW UP WITH THE IBC VIA EMAIL ON (B)(6) 2020 IT WAS STATED THAT THE CUSTOMER COULD NOT OBTAIN THE DETAILED INFORMATION OF THE PLACE WHERE THE FOREIGN MATERIAL WAS FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10951519 ↗MalfunctionOct 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE FOREIGN MATERIAL (DUST ADHESION) WAS FOUND ON THE SYRINGE. PER FOLLOW-UP VIA IBC ON 13OCT2020, THE FOREIGN MATERIAL WAS PRESENT INSIDE THE SYRINGE UPON OPENING THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10755576 ↗MalfunctionOct 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A HAIR WAS FOUND IN THE DEVICE.
Patient problems: No Patient Involvement
MAUDE report 10711105 ↗MalfunctionOct 1, 2020Use of Device Problem; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT HAIR WAS FOUND IN SYRINGE ONCE OPENED ONTO SPINE SET UP. IT WAS ALSO STATED THAT COMPLETE SET UP NEEDED TO BE CHANGED.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10615066 ↗MalfunctionJul 10, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE FOREIGN MATERIAL WAS FOUND WHEN THE PACKAGE WAS OPENED. PER ADDITIONAL INFORMATION, RECEIVED VIA EMAIL ON 19JUN2020 FROM IBC REPRESENTATIVE, FOREIGN MATERIAL WAS FOUND INSIDE THE SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 10258695 ↗MalfunctionJul 7, 2020Unsealed Device Packaging; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT HAIR WAS FOUND WHEN THE PACKAGE WAS OPENED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 19 JUN 2020 FROM IBC REPRESENTATIVE, FOREIGN MATERIAL WAS ATTACHED TO THE CONNECTION BETWEEN VALVE AND THE SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10240540 ↗MalfunctionJul 1, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGE WAS PARTIALLY EMPTY BEFORE OPENING. BASED ON PHOTOS ATTACHED, NO PRODUCT WAS MISSING FROM THE PACKAGE BUT APPEARED TO BE SLIGHTLY OPEN.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10220042 ↗MalfunctionJun 26, 2020Contamination /Decontamination Problem
IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND INSIDE THE SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10201429 ↗MalfunctionJun 23, 2020Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT HAIR WAS FOUND INSIDE THE SYRINGE WITHIN THE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10185326 ↗MalfunctionJun 16, 2020Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE FOREIGN MATERIAL FOUND INSIDE THE SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10159189 ↗MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 24 MARCH 2020 FROM IBC REPRESENTATIVE, THE FOREIGN MATERIAL WAS FOUND INSIDE THE SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9958200 ↗MalfunctionMar 23, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE USER FOUND FOREIGN MATERIAL (LIKE A BLACK INK STAIN) ON THE BULB IRRIGATION SYRINGE PRIOR TO USE. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 01-MAR-2020, THERE WAS A BLACK MATERIAL OR MARK JUST BETWEEN THE SEAL OF WHERE THE BULB AND SYRINGE CAME TOGETHER.
Patient problems: No Patient Involvement
MAUDE report 9866432 ↗MalfunctionFeb 27, 2020Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL (HAIR) INSIDE THE SYRINGE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9765818 ↗MalfunctionFeb 24, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BLACK FOREIGN MATERIAL WAS FOUND. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17 FEB 2020 FROM IBC REPRESENTATIVE, IT SEEMED THAT THE FOREIGN MATERIAL WAS FOUND INSIDE THE SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9745450 ↗MalfunctionFeb 19, 2020Defective Device; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE OPENING AT THE TIP OF THE IRRIGATION SYRINGE BULB WAS NOT PUNCHED DURING MANUFACTURING.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9729648 ↗MalfunctionSep 20, 2019Contamination /Decontamination Problem
IT WAS REPORTED THAT A FOREIGN MATERIAL LIKE DIRT WAS FOUND INSIDE THE IRRIGATION BULB BEFORE USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9100032 ↗MalfunctionJul 10, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATERIAL (HAIR) WAS INSIDE THE BULB IRRIGATION SYRINGE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8776439 ↗MalfunctionJul 3, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE USER FOUND DIRT ON THE DEVICE PRIOR TO USE. IT WAS LATER REPORTED VIA EMAIL FROM THE INTERNATIONAL BUSINESS CENTER REPRESENTATIVE ON 20-JUNE-19, THE FOREIGN MATERIAL WAS INTERNAL.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8757748 ↗
Other SYRINGE, IRRIGATING (NON DENTAL) devices
- Irrigation Syringe 0935280C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)83 reports
- N/A 309620Becton, Dickinson And Company · SYRINGE, IRRIGATING (NON DENTAL)73 reports
- MEDLINE DYND20125Medline Industries, Inc. · SYRINGE, IRRIGATING (NON DENTAL)1 recall3 reports
- NICO Fluid System NN-8015Nico Corporation · Syringe, Irrigating (Non Dental)1 recall0 reports
- Rapid Refill M00566000Boston Scientific 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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