Cook G00219Recalls & reported problems
Cook Incorporated · Plastic 3-Way Stopcock · Class 1
Quick summary
This Cook 3-way plastic stopcock is a small valve used on catheter lines. Many of its 103 reports describe fluid or blood leaking or splashing, and cracks or fractures in the plastic body. Most reports note no impact on patients. The reports mention no deaths and 1 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
- 103
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00827002002197), received between Jun 16, 2016 and Nov 29, 2021 — classified as 1 injury, 102 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (46 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak46
- Leak/Splash38
- Crack18
- Fracture10
- Break3
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient38
- No Patient Involvement28
- No Consequences Or Impact To Patient26
- No Clinical Signs, Symptoms or Conditions16
- No Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2021Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12882655 ↗MalfunctionNov 23, 2021Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12862390 ↗MalfunctionSep 1, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
2 DEVICES OF THE SAME LOT NUMBER LEAKED DURING THE SAME PROCEDURE. THE FIRST DEVICE WAS RETURNED TO COOK FOR INVESTIGATION ON (B)(6) 2021 AND THE 2ND DEVICE WAS RETURNED (B)(6) 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12410105 ↗MalfunctionAug 30, 2021Leak/Splash; Leak/Splash
NO NEW PATIENT OR PROCEDURAL INFORMATION TO REPORT SINCE THE PREVIOUS MDR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12388190 ↗MalfunctionAug 30, 2021Leak/Splash; Leak/Splash
NO NEW PATIENT OR PROCEDURAL INFORMATION TO REPORT THAT WAS NOT INCLUDED ON THE PREVIOUS MDR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12387774 ↗MalfunctionAug 30, 2021Leak/Splash; Leak/Splash
NO NEW PATIENT OR PROCEDURAL INFORMATION TO REPORT THAT WAS NOT INCLUDED ON THE PREVIOUS MDR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12387741 ↗MalfunctionAug 16, 2021Leak/Splash; Leak/Splash
TWO DEVICES OF THE SAME LOT WERE RETURNED. BOTH DEVICES SHOWED EVIDENCE OF LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12325209 ↗MalfunctionJul 28, 2021Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION RECEIVED ON 03AUG2021: FIVE DEVICES WERE RETURNED FOR INVESTIGATION, ONE USED AND FOUR UNUSED. THE USED STOPCOCK HAD A CRACK AND LEAKED, AS INITIALLY REPORTED. OF THE FOUR UNUSED DEVICES, THREE HAD VISIBLE CRACKS AND ONE HAD NO VISIBLE DAMAGE. THE DEVICES WERE LEAK TESTED AND TWO OF THE CRACKED STOPCOCKS LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12241006 ↗MalfunctionJul 28, 2021Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED 05NOV2021. THE PROCEDURE INVOLVED ADMINISTRATION OF CHEMOTHERAPY AND AN UNKNOWN CATHETER WAS USED WITH THE COMPLAINT DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER UNSPECIFIED THREE-WAY STOPCOCK. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12240893 ↗MalfunctionJul 9, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12144533 ↗MalfunctionApr 29, 2021Fluid/Blood Leak; Fluid/Blood Leak
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11744277 ↗MalfunctionApr 9, 2021Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION WAS RECEIVED 01JUN2021. SEVEN STOPCOCKS LEAKED AT THE HUB, NOT NINE AS ORIGINALLY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11640446 ↗MalfunctionMar 25, 2021Fluid/Blood Leak; Fluid/Blood Leak
NO NEW PATIENT OR EVET INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11568692 ↗MalfunctionFeb 26, 2021Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
AS REPORTED, WHILE TESTING A THREE-WAY PLASTIC STOPCOCK, THERE WAS LEAKAGE NOTED THROUGH THE CENTRAL PART OF THE DEVICE (NOT THROUGH THE SCREW THREAD). THIS ISSUE OCCURRED ON SEVEN STOPCOCKS THAT WERE BEING TESTED (PATIENT REFERENCE (B)(4)). THE LAST TWO WERE TESTED WITH SALINE SOLUTION WITHOUT LIPOIDAL. THERE WERE NO CLINICAL CONSEQUENCES OBSERVED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11387736 ↗MalfunctionFeb 26, 2021Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
AS REPORTED, WHILE TESTING A THREE-WAY PLASTIC STOPCOCK, THERE WAS LEAKAGE NOTED THROUGH THE CENTRAL PART OF THE DEVICE (NOT THROUGH THE SCREW THREAD). THIS ISSUE OCCURRED ON SEVEN STOPCOCKS THAT WERE BEING TESTED (PATIENT REFERENCE (B)(4). THE LAST TWO WERE TESTED WITH SALINE SOLUTION WITHOUT LIPOIDAL. THERE WERE NO CLINICAL CONSEQUENCES OBSERVED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11387661 ↗MalfunctionFeb 22, 2021Crack; Crack
THIS FILE IS RELATED TO PATIENT REFERENCE (B)(4). WHEN THE DEVICE WAS RETURNED FOR PATIENT REFERENCE (B)(4), FOUR ADDITIONAL SEALED DEVICES WERE ALSO RETURNED THAT HAD CRACKS IN THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11358223 ↗MalfunctionDec 16, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11019210 ↗MalfunctionSep 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10558393 ↗MalfunctionSep 15, 2020Leak/Splash; Leak/Splash
AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE A THREE-WAY PLASTIC STOPCOCK WAS BEING PREPARED WITH SURGICAL GLUE WHEN IT WAS FOUND TO LEAK. ANOTHER THREE-WAY PLASTIC STOPCOCK WAS THEN, OPENED, AND BEING PREPARED IN SIMILAR FASHION WHEN IT, TOO, WAS FOUND TO LEAK. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT RESULT IN ADDITIONAL PROCEDURES, OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10534401 ↗MalfunctionSep 15, 2020Leak/Splash; Leak/Splash
AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE A THREE-WAY PLASTIC STOPCOCK WAS BEING PREPARED WITH SURGICAL GLUE WHEN IT WAS FOUND TO LEAK. ANOTHER THREE-WAY PLASTIC STOPCOCK WAS THEN OPENED AND BEING PREPARED IN SIMILAR FASHION WHEN IT, TOO, WAS FOUND TO LEAK. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT RESULT IN ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10534245 ↗MalfunctionSep 14, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A CHEMOEMBOLIZATION PROCEDURE, A THREE-WAY PLASTIC STOPCOCK LEAKED CHEMOTHERAPEUTIC AND CONTRAST AGENTS (DOXORUBICIN AND LIPIODOL). THE DRUGS LEAKED FROM THE DEVICES ONTO THE TABLE AND FLOOR, POSING A RISK OF SPLASHING. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10528756 ↗MalfunctionSep 14, 2020Leak/Splash; Leak/Splash
AS REPORTED, DURING A PELVIC EMBOLIZATION THE USER WAS INJECTING "GLUE" INTO THE THREE-WAY PLASTIC STOPCOCK, BUT FOUND THE DEVICE TO LEAK. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT RESULT IN ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10527657 ↗MalfunctionSep 14, 2020Leak/Splash; Leak/Splash
AS REPORTED, DURING A PELVIC EMBOLIZATION THE USER WAS INJECTING "GLUE" INTO THE THREE-WAY PLASTIC STOPCOCK, BUT FOUND THE DEVICE TO LEAK. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT RESULT IN ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10527655 ↗MalfunctionAug 4, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10361361 ↗MalfunctionJun 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10148487 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.