Jelco 96004Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00351688065585), received between Jun 22, 2018 and Sep 22, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Fluid/Blood Leak

  It was reported that the product seems to be leaked. Paramedic had the device on top of a blood culture bottle, and there was a leak he looked down and found blood all over his shoe. When the rubber separated from the needle, blood flows freely. This occurred when moved from one blood culture bottle to the next. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855595 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  It was reported that the product seems to be leaked. Paramedic had the device on top of a blood culture bottle, and there was a leak he looked down and found blood all over his shoe. When the rubber separated from the needle, blood flows freely. This occurred when moved from one blood culture bottle to the next. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855377 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  It was reported that the product seems to be leaked. Paramedic had the device on top of a blood culture bottle, and there was a leak he looked down and found blood all over his shoe. When the rubber separated from the needle, blood flows freely. This occurred when moved from one blood culture bottle to the next. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855173 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845441 ↗
• MalfunctionApr 6, 2026Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE BLOOD CULTURE ADAPTER BROKE OFF IN IV HUB WHEN ATTEMPTING TO DISCONNECT IT RESULTING IN THE IV HUB TO LEAKED BLOOD AND REQUIRED THE IV LINE TO BE CHANGED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789322 ↗
• MalfunctionDec 26, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A VACUTAINER WAS ATTACHED TO THE CLEAR LINK ON THE ARTERIAL LINE TUBING FOR A BLOOD DRAW. THE SST AND GREEN-TOP TUBES FILLED WITHOUT ISSUE. WHEN THE CBC (PURPLE-TOP) TUBE WAS INSERTED INTO THE VACUTAINER, IT FILLED ONLY APPROXIMATELY ONE-QUARTER OF THE TUBE. A PTT (BLUE-TOP) TUBE WAS THEN INSERTED, AT WHICH TIME THE REGISTERED NURSE HEARD A BURST OF AIR. IMMEDIATELY FOLLOWING THE SOUND, BLOOD WAS OBSERVED LEAKING AROUND THE CONNECTION SITE. THE VACUTAINER WAS PROMPTLY REMOVED. UPON INSPECTION, A PORTION OF THE VACUTAINER WAS NOTED TO BE ENLARGED AND BROKEN, WITH THE BROKEN PIECE VISUALIZED INSIDE THE CLEAR LINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896514 ↗
• MalfunctionJul 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LUER LOCK PIECE CAME OFF, AND BLOOD DRIPPED OUT WHILE IN USE WITH THE PATIENT. THE EVENT HAPPENED IN THE HOSPITAL, OPERATED BY A HEALTH PROFESSIONAL. THERE WAS NO INJURY. THERE WERE 4 AFFECTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479608 ↗
• MalfunctionJun 14, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE APPARENTLY BROKE OFF INTO THE BOTTLE ITSELF WHILE COLLECTING BLOOD. SUBSEQUENTLY, THE LUER LOCK PIECE ALSO BROKE WHILE COLLECTING BLOOD FROM THE PATIENT. THIS RESULTED IN REQUIRING THE PATIENT TO GET A NEW IV AS THEY COULD NOT REMOVE THE BROKEN LUER LOCK OFF THE IV HUB. NO MEDICAL INTERVENTION WAS PROVIDED. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208136 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT IS LEAKING WHILE IN USE. THE DEVICE FAULT OCCURRED WHILE DRAWING THE BLOOD CULTURES. THE DEVICE WAS CRACKING INSIDE NEAR WHERE IT CONNECTS TO THE IV SALINE LOCK, CAUSING BLOOD TO LEAK OUT. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857316 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT IS LEAKING WHILE IN USE. THE DEVICE FAULT OCCURRED WHILE DRAWING THE BLOOD CULTURES. THE DEVICE WAS CRACKING INSIDE NEAR WHERE IT CONNECTS TO THE IV SALINE LOCK, CAUSING BLOOD TO LEAK OUT. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856631 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT IS LEAKING WHILE IN USE. THE DEVICE FAULT OCCURRED WHILE DRAWING THE BLOOD CULTURES. THE DEVICE WAS CRACKING INSIDE NEAR WHERE IT CONNECTS TO THE IV SALINE LOCK, CAUSING BLOOD TO LEAK OUT. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856493 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT IS LEAKING WHILE IN USE. THE DEVICE FAULT OCCURRED WHILE DRAWING THE BLOOD CULTURES. THE DEVICE WAS CRACKING INSIDE NEAR WHERE IT CONNECTS TO THE IV SALINE LOCK, CAUSING BLOOD TO LEAK OUT. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856069 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT IS LEAKING WHILE IN USE. THE DEVICE FAULT OCCURRED WHILE DRAWING THE BLOOD CULTURES. THE DEVICE WAS CRACKING INSIDE NEAR WHERE IT CONNECTS TO THE IV SALINE LOCK, CAUSING BLOOD TO LEAK OUT. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855776 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT IS LEAKING WHILE IN USE. THE DEVICE FAULT OCCURRED WHILE DRAWING THE BLOOD CULTURES. THE DEVICE WAS CRACKING INSIDE NEAR WHERE IT CONNECTS TO THE IV SALINE LOCK, CAUSING BLOOD TO LEAK OUT. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855725 ↗
• InjuryJun 11, 2024Loose or Intermittent Connection; Material Separation; Physical Resistance/Sticking; Loose or Intermittent Connection; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LUER LOCK FROM THE ADAPTER WAS DISLODGED AND GOT STUCK IN THE PATIENT'S IV EXTENSION. THE NURSE TRIED TO REMOVE THE NEEDLE AND GOT STUCK WITH THE NEEDLE. AS A RESULT, THE CLINICIAN HAD TO GO TO THE EMERGENCY ROOM AND HAVE BLOOD LAB TESTING DONE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM, AND CLINICIAN HARM/ADVERSE EVENT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19510208 ↗
• MalfunctionMay 29, 2024Break; Break

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF AT THE BASE AND THE PIGTAIL (IV EXTENSION SET) HAD TO BE CHANGED BECAUSE THERE WAS PIECE OF THE NEEDLE LEFT IN THE HUB/PORT OF THE EXTENSION SET. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19415447 ↗
• MalfunctionMay 29, 2024Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

  IT WAS REPORTED THAT THE ENTIRE NEEDLE CAME OFF CAUSING BLOOD TO FLOW FREELY AND THE NEED TO CHANGE OUT THE CULTURE DEVICE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19415369 ↗
• MalfunctionJul 13, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE RN APPLIED THE VACUTAINER TO PATIENTS IV TO REDRAW BLOOD. WHILE REDRAWING BLOOD FROM THE IV, THE RN NOTICED THAT THERE WERE DROPS OF BLOOD COMING FROM THE VACUTAINER AND LINE. RN WENT TO INVESTIGATE THE HUB OF THE IV AND THE VACUTAINER FELL OFF OF THE IV. THE MIDDLE OF THE VACUTAINER WAS BROKEN OFF INTO THE HUB OF THE IV AND WAS LEAKING BLOOD ONTO THE PATIENT AND BED. RN HAD TO SWITCH THE HUB COMPLETELY OFF OF THE IV TO STOP THE BLOOD FLOW. THE VACUTAINER WAS BROKEN ON THE SIDE AND IN THE MIDDLE. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17317774 ↗
• MalfunctionJul 13, 2023Fluid/Blood Leak; Fail-Safe Did Not Operate; Fluid/Blood Leak; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE RN ACCESSED AN IV WITH A DEVICE, ATTACHED 1 EDTA (ETHYLENEDIAMINE TETRAACETIC ACID) TUBE WHICH FILLED. REMOVED EDTA TUBE AND BLOOD CONTINUED TO FLOW OUT OF THE IV, FILLING THE HUB AND DRIPPING ON THE FLOOR. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17317764 ↗
• MalfunctionJul 13, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE "END PART BROKE OFF". SIGNIFICANT BLOOD LEAKAGE OCCURRED. THERE WAS NO PATIENT HARM, INJURY, OR ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317757 ↗
• MalfunctionJul 13, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE "END PART BROKE OFF". SIGNIFICANT BLOOD LEAKAGE OCCURRED. THERE WAS NO PATIENT HARM, INJURY, OR ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317756 ↗
• MalfunctionOct 6, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A NURSE WENT TO DRAW BLOOD AND WAS NOT ABLE TO DRAW. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552208 ↗
• MalfunctionSep 11, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH A BROKEN DISTAL PORT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397859 ↗
• MalfunctionSep 4, 2022Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT TWO COMPONENTS BROKE DURING NORMAL USE AT THE LUER LOCK ADAPTER LEAVING PIECES EMBEDDED IN THE NEEDLE-LESS CLAVE ON THE INTRAVENOUS (IV) PIGTAIL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353771 ↗
• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE APART AT THE LUER LOCK ADAPTER SECTION LEAVING A PIECE EMBEDDED IN THE NEEDLE-LESS CLAVE ON THE INTRAVENOUS (IV) PIGTAIL. THE PATIENT'S PIGTAIL NEEDED TO BE REMOVED DUE TO A CONTINUOUS LEAK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337044 ↗