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NA TAL101Recalls & reported problems

Pajunk Medical Systems, LP · CONTINUOUS EPIDURAL TRAY Tuohy Epidural Needle 17G x 4“ with EpiLong Soft Catheter, Closed Tip, 19G · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858965006007), received between Jul 26, 2019 and Oct 9, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier.

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. Oct 10, 2022Terminated

    The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.

    Z-0278-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component2
  • Entrapment of Device1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ON (B)(6) 2019 AFTER PLACING THE EPIDURAL CATHETER IN A LABORING PATIENT, THE ANESTHESIOLOGIST WAS WITHDRAWING THE TUOHY NEEDLE (ITEM CODE (B)(4)) SLOWLY WITH NO UNUSUAL RESISITANCE WHEN THE PLASTIC PART OF THE END OF THE NEEDLE BROKE OFF. THE DOCTOR STATES HE WAS NOT PULLING HARD ON THE NEEDLE. THE NEEDLE WAS PACKAGED IN AN EPIDURAL CONVENIENCE KIT, ITEM CODE (B)(4). THE ANESTHESIOLOGIST WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE KIT THAT WAS USED. THE PROCEDURE WAS FOR THE MOST PART COMPLETE AND THE PATIENT WAS NOT AFFECTED IN ANY WAY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9171711 ↗
  • MalfunctionJul 26, 2019Entrapment of Device; Detachment of Device or Device Component

    ON (B)(6) 2019, PAJUNK RECEIVED A COMPLAINT REPORT ON THE EPILONG SOFT TRAY 17G X 103MM NEEDLE IN THE TAL101 EPIDURAL ANESTHESIA KIT. THE RED CAP ON THE PLASTIC STYLET CAME OFF THE STYLET WHEN BEING PULLED OUT OF THE NEEDLE CAUSING THE STYLET TO GET STUCK IN THE NEEDLE. THIS OCCURRED 6 TIMES IN OVER 2 WEEKS. NO PATIENTS SUFFERED INJURY DUE TO THIS INCIDENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8833699 ↗

Other Epidural Anesthesia Kit devices

All Epidural Anesthesia Kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.