Design Options® 552006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964311215), received between Jan 22, 2019 and Feb 9, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 18, 2025Open, Classified

   Potential for the lid of the catheter connector to be in the incorrect position.

   Z-0126-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: WHILE GIVING LOCAL ANESTHESIA VIA 30 GAUGE 1 INCH NEEDLE THE TIP OF THE NEEDLE BROKE OFF SUBCUTANEOUSLY IN THE PATIENT. PER END USER; THE NEEDLE WAS REMOVED, THERE WAS NO FURTHER INTERVENTION THAT WAS OUTLINED IN THE REPORT. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13497675 ↗
• MalfunctionFeb 4, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: COMPLAINT REPORT STATES THAT A 30 GAGE HYPODERMIC NEEDLE BROKE OFF FROM THE HUB IN THE PATIENT. DETAILS OF THE INCIDENT, THE CLINICIAN CLEANED THE PATIENT'S BACK AND ADMINISTERED THE LOCAL ANESTHETIC (SKIN WHEAL). UPON REMOVING THE SYRINGE, SHE NOTICED THAT THE NEEDLE HAD BROKEN OFF THE HUB OF THE SYRINGE AND REMAINED IN THE PATIENT'S BACK.

  Patient problems: Foreign Body In Patient

  MAUDE report 9665126 ↗
• MalfunctionSep 17, 2019Break; Break

  AS REPORTED BY USER FACILITY: IT WAS REPORTED THAT, "THE INCIDENT OCCURRED DURING CATHETER INSERTION. THE ADVANCEMENT WAS DIFFICULT AND THE PATIENT NEEDED TO BE REPOSITIONED AND MAYBE THE CATHETER GOT PINCHED. WE DID A CT SCAN AND DID NOT VISUALIZE THE CATHETER. IT LOOKED LIKE THE SPRING WOUND PIECE CAME OUT IN ITS ENTIRETY. ANOTHER CATHETER WAS INSERTED IN A DIFFERENT LOCATION."

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 9075104 ↗
• MalfunctionJan 22, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS, POTENTIAL EPIDURAL CATHETER SHEARING. CRNA WAS PERFORMING A STANDARD EPIDURAL PLACEMENT. CATHETER WAS PLACED AS USUAL. CRNA TRIED TO REPOSITION THE CATHETER AND ENCOUNTERED RESISTANCE. UPON BEING UNABLE TO MANIPULATE THE CATHETER THE CATHETER AND NEEDLE WERE REMOVED. ONCE REMOVED THE CRNA NOTED THAT THE TIP OF THE CATHETER WAS MISSING AND INNER WIRE OF THE CATHETER WAS EXPOSED. THE CATHETER'S INNER WIRE COIL WAS INTACT BUT THE TIP OF THE CATHETER WAS MISSING ABOUT 2CM OF THE SOFT POLYAMIDE. CATHETER WAS REMOVED AND A SECOND CATHETER WAS PLACED. PATIENT WAS DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8267650 ↗