Jelco 3085Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10351688071309), received between May 14, 2018 and Jul 10, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Material Twisted/Bent; Protective Measures Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT WITH THE DEVICE WHEN TRYING TO START AN IV ON A PATIENT THAT THE DEVICE WAS BENT AND DID NOT DEPLOY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714993 ↗
• MalfunctionMay 5, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A "WRITER" WAS USED TO INITIATE AN IV. AN 18G NEEDLE WAS USED TO ATTEMPT THE LINE IN THE LEFT ANTECUBITAL (AC). UPON THREADING IV CANNULA, RESISTANCE FELT, FLASH OF BLOOD SEEN INITIALLY, BUT NOT DURING THREADING. THE "WRITER" ATTEMPTED TO PULL IV CANNULA OUT AS PATIENT COMPLAINING OF PAIN AND RESISTANCE TO THREADING FELT, BUT INCREASED RESISTANCE FELT BY WRITER WHEN ATTEMPTING TO PULL IV CANNULA OUT. AFTER INITIAL RESISTANCE, WRITER FELT SUDDEN RELEASE OF TENSION, AND IV CANNULA WAS REMOVED FROM PATIENT'S AC. ON INSPECTION OF IV CANNULA, CANNULA WAS NOTED TO BE SHORTER THAN NORMAL WHEN COMPARED TO INTACT IV CANNULA OF SAME GAGE AND END-PIECE NOTED TO BE JAGGED ON THE EDGE. THE PATIENT'S AC WAS FELT, NO BUMPS OR BRUISING NOTED, PATIENT REMAINED VITALLY STABLE THROUGHOUT, NOT COMPLAINING OF PAIN POST REMOVAL OF IV CATHETER. DRESSING AND PRESSURE APPLIED TO PATIENT'S LEFT AC MAINTAINED FOR 2 MINUTES POST REMOVAL OF IV CANNULA. PATIENT AWARE OF COMPLICATIONS ON IV ATTEMPT, DENIED QUESTIONS WHEN ASKED BY WRITER. THE END PIECE THAT BROKE OFF WAS NEVER LOCATED. THE PRIMARY NURSE AND OTHER USER PALPATED THE AREA AND WERE UNABLE TO LOCATE THE END-PIECE. THE EMERGENCY PH

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 16879502 ↗
• InjuryNov 16, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CATHETER HAD RESISTANCE UPON REMOVAL. HALF OF THE CATHETER WAS MISSING WHEN IT WAS REMOVED FROM THE PATIENT. THIS PIECE WAS REMOVED THE FOLLOWING DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081921 ↗
• MalfunctionMay 18, 2018Positioning Failure; Positioning Failure

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® PROTECTIV® SAFETY I.V. CATHETER DID NOT HAVE A SHARP RETRACT; SHARP DID NOT RETRACT AS NO MOVEMENT OCCURED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527385 ↗
• MalfunctionMay 18, 2018Positioning Failure; Positioning Failure

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® PROTECTIV® SAFETY I.V. CATHETER DID NOT HAVE A SHARP RETRACT; SHARP DID NOT RETRACT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527304 ↗
• InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A JELCO® PROTECTIV® SAFETY I.V. CATHETER HAS BEEN SET ON THE (B)(6) 2017 ON A PATIENT BY A NURSE. ON THE MORNING OF THE (B)(6) 2017, A LYMPHANGITIS APPEARED IN PATIENT'S ARM BEFORE THE CORONOGRAPHY TEST.

  Patient problems: Reaction, Injection Site

  MAUDE report 7511355 ↗