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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

All SYRINGE, IRRIGATING (NON DENTAL) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.