Jelco 982312DRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 20351688081770), received between Jun 7, 2017 and Aug 12, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025No Fail-Safe Mechanism; No Fail-Safe Mechanism

  IT WAS STATED THAT A SHARPS EXPOSURE OCCURRED BECAUSE THE SAFETY MECHANISM ON A BUTTERFLY NEEDLE DID NOT ENGAGE PROPERLY. THE MECHANISM OF INJURY WAS THAT, WHILE ATTEMPTING TO ENGAGE THE SAFETY MECHANISM, THE INDIVIDUAL GOT THEIR FINGERTIP STUCK. UPON TESTING, THE SAFETY MECHANISM FELT TIGHTER THAN USUAL AND STOPPED HALFWAY THROUGH THE SLIDE. IT COULD BE ENGAGED WITH A STRONG PULL, BUT IT WAS NOTICEABLY TIGHTER THAN OTHER DEVICES. THIS INCIDENT RESULTED IN A NEEDLESTICK INJURY. THE FAULT WAS IDENTIFIED DURING TESTING, AND NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22786901 ↗
• MalfunctionMar 25, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THERE WAS A NEEDLE STICK INJURY ON A PHLEBOTOMIST AS THE NEEDLE'S SAFETY WAS NOT ENGAGING COMPLETELY. THE EVENT OCCURRED DURING POST PROCEDURE AT THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS HEALTH PROFESSIONAL. THE ISSUE WAS RESOLVED. THE MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21691810 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT UPON RETRACTING THE NEEDLE FROM THE PATIENT'S ARM THE TUBING BROKE AND BLOOD SPATTERED ON THE MEDICS ARMS AND UPPER TORSO. NO ADVERSE PATIENT OR CLINICAL EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873556 ↗
• MalfunctionAug 31, 2022Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE USERS ARE EXPERIENCING ISSUES WITH THREADING WHILE CONNECTING THE VACUTAINER TO THE NEEDLE: "ONE POPPED OFF" AND THAT THE PLASTIC BAND THAT HOLDS THE TUBING TOGETHER DID NOT COME OFF EASILY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327504 ↗
• MalfunctionAug 31, 2022Peeled/Delaminated; Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Peeled/Delaminated; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT THREADING OCCURRED WHEN CONNECTING THE VACUTAINER TO THE NEEDLE. THERE WERE TWO (2) ACCIDENTAL NEEDLE POKES DUE TO THE PLASTIC BAND THAT HELD THE TUBING WAS DIFFICULT TO REMOVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327397 ↗
• MalfunctionAug 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE PULLING THE SAFETY DEVICE UP, THE NEEDLE DETACHED FROM THE TUBING AND SHOT ACROSS THE ROOM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327374 ↗
• MalfunctionMar 8, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE IS MISSING OR THERE IS A DEFECT PREVENTING THE NEEDLE FROM COMING OUT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13696009 ↗
• MalfunctionMar 8, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE NEEDLE IS MISSING OR THERE IS A DEFECT PREVENTING THE NEEDLE FROM COMING OUT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694868 ↗
• InjuryMay 8, 2021Difficult to Fold, Unfold or Collapse; Difficult to Open or Close; Difficult to Fold, Unfold or Collapse; Difficult to Open or Close

  IT WAS REPORTED THAT A BLOOD BORNE PATHOGEN EXPOSURE BECAUSE THE BUTTERFLY NEEDLE SHEATH SPLIT APART EXPOSING THE DIRTY NEEDLE, BREACHING THEIR GLOVE AND PIERCING HER INDEX FINGER. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11795359 ↗
• MalfunctionJul 13, 2017Retraction Problem; Protective Measures Problem; Retraction Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE BUTTERFLY NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET WOULD NOT RETRACT PROPERLY AFTER A BLOOD DRAW ON AN OUTPATIENT LAB PATIENT. THE OPERATOR TOOK THE NEEDLE OUT OF THE PATIENT'S ARM BECAUSE IT WOULD NOT RETRACT PROPERLY. WITH ABOUT HALF OF AN INCH OF THE NEEDLE STILL EXPOSED, THE OPERATOR AGAIN TRIED TO RETRACT IT AFTER IT WAS REMOVED FROM THE PATIENT, AND THE NEEDLE STILL WOULD NOT RETRACT. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711902 ↗
• MalfunctionJul 13, 2017Retraction Problem; Protective Measures Problem; Retraction Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE BUTTERFLY NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET WOULD NOT RETRACT PROPERLY AFTER A BLOOD DRAW ON AN OUTPATIENT LAB PATIENT. THE OPERATOR TOOK THE NEEDLE OUT OF THE PATIENT'S ARM BECAUSE IT WOULD NOT RETRACT PROPERLY. WITH ABOUT HALF OF AN INCH OF THE NEEDLE STILL EXPOSED, THE OPERATOR AGAIN TRIED TO RETRACT IT AFTER IT WAS REMOVED FROM THE PATIENT, AND THE NEEDLE STILL WOULD NOT RETRACT. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711900 ↗
• MalfunctionJul 7, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NURSE WAS UNABLE TO RETRACT THE NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET INTO THE HOUSING. THE NEEDLE WOULD ONLY RETRACT HALF WAY. NEEDLE WAS DISPOSED OF IN SHARPS CONTAINER. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6694491 ↗
• MalfunctionJul 7, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NURSE WAS UNABLE TO RETRACT THE NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET INTO THE HOUSING. THE NEEDLE WOULD ONLY RETRACT HALF WAY. NEEDLE WAS DISPOSED OF IN SHARPS CONTAINER. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6694487 ↗
• InjuryJun 30, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE TUBING OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET PULLED AWAY FROM THE NEEDLE, LEADING TO A NEEDLE STICK. THE PHLEBOTOMIST COLLECTED A VENOUS SPECIMEN WITH THE BLOOD COLLECTION SET FROM AN ADULT PATIENT. WHEN THE PHLEBOTOMIST PULLED BACK ON THE TUBING TO ACTIVATE THE SAFETY FEATURE, THE TUBING WAS HARD TO PULL. THE PHLEBOTOMIST PULLED A SECOND TIME A HEARD THE "CLICK", WHICH MEANS THE NEEDLE SHOULD BE RETRACTED. THE TUBING HAD PULLED AWAY FROM THE HUB OF THE NEEDLE. THE PHLEBOTOMIST PICKED UP THE BUTTERFLY AND WAS STUCK BY THE NEEDLE BECAUSE THE BEVEL END OF THE NEEDLE HAD NOT RETRACTED. THE PHLEBOTOMIST DISPOSED OF THE PRODUCT IN THE SHARPS CONTAINER. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6682114 ↗
• MalfunctionJun 7, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET WAS DIFFICULT TO RETRACT INTO THE "HOUSING". NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619538 ↗
• MalfunctionJun 7, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET WAS DIFFICULT TO RETRACT INTO THE "HOUSING". NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619536 ↗
• MalfunctionJun 7, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET WAS DIFFICULT TO RETRACT INTO THE "HOUSING". NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619531 ↗
• MalfunctionJun 7, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET WAS DIFFICULT TO RETRACT INTO THE "HOUSING". NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619530 ↗
• MalfunctionJun 7, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET WAS DIFFICULT TO RETRACT INTO THE "HOUSING". NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619529 ↗
• MalfunctionJun 7, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET WAS DIFFICULT TO RETRACT INTO THE "HOUSING". NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619527 ↗