Dover 67000Recalls & reported problems
Cardinal Health, Inc. · Bulb Syringe,Irrigation with Protective Cap · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521007994), received between Dec 9, 2022 and Dec 9, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- Low Blood Pressure/ Hypotension1
- Muscle Weakness/Atrophy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE CLEAR PLASTIC PART OF THE BALL SUCTION CAME OFF THE BALL AND FELL ONTO THE PATIENT'S CORD. ADDITIONAL INFORMATION RECEIVED ON 28NOV2022 STATED THAT THE PATIENT UNDERWENT A CERVICAL LAMINECTOMY, SO THE SPINAL CORD (COVERED BY DURA) WAS EXPOSED AND UNPROTECTED BY THE BONE. THE ENTIRE CLEAR PIECE (SYRINGE) FILLED WITH NORMAL SALINE SEPARATED FROM THE GREEN RUBBER BALL AND FELL ONTO THE EXPOSED DURA/SPINAL CORD. IT WAS IMMEDIATELY REMOVED FROM THE SURGICAL FIELD. THERE WAS A DECLINE IN THE NEUROMONITORING DURING THE CASE AND THEY HAD TO ELEVATE THE BLOOD PRESSURE TO MAPS > 85. THE PATIENT DID HAVE SOME POSTOPERATIVE WEAKNESS WHICH HAS NOW RESOLVED.
Patient problems: Low Blood Pressure/ Hypotension; Muscle Weakness/Atrophy
MAUDE report 15953316 ↗
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
- Irrigation Syringe 0035280C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)58 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.