MAUDE Adverse Event Report: HAKKO CO., LTD TUOHY EPIDURAL NEEDLE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number 6-2150-17

Device Problem Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/06/2018

Event Type  Injury  

Event Description

Patient was placed into standard seated position for epidural placement.Anatomical landmarks were attempted to be isolated, however due to patient's body habitus, neither pelvic brim, nor individual spinous process could be palpated.A wide area in the presumed l3/4 area was cleaned using standard chloroprep technique and a sterile drape was applied.The planned area for needle insertion was subcutaneously injected with 3ml of 1% lidocaine and an initial attempt was made with the standard tuohy needle (17g, 11cm long) available in the epidural kit.The needle was advanced to the hub without loss of resistance and i decided to use a longer tuohy needle.A 6 inch, 17g tuohy needle was advanced and an initial loss of resistance was felt at the 11 cm mark.The catheter was threaded; however, blood was noted to return through the catheter so it was removed and the needle was pulled back.The introducer was replaced and a second pass with the long needle was attempted.Once again, no loss of resistance was noted.There had been some increased resistance to needle advancement, however, it was no more than had been experienced during previous epidural placements in other patients.As the needle was being withdrawn to re-direct and attempt a third pass, a sudden loss of resistance was noted and 6 cm of needle was withdrawn, leaving approximately 9cm of needle inside the body of the patient.An emergency consult from general surgery was obtained and a decision was made to move the patient into a right lateral decubitus position and transfer to the main or to retrieve the retained piece of needle.The patient was consented for the procedure to be done under local anesthetic only and was taken to main or where she underwent an uneventful procedure.The needle piece was removed without incident and the incision was closed in standard fashion in two layers with a waterproof dressing applied in a sterile fashion.While in the o.R., an epidural was placed under sterile conditions.Loss of resistance was noted to be at 12cm and the catheter was advanced to a depth of 17cm at the skin, and secured with sterile dressing and tape.The patient was then transferred back to her labor room and her epidural was bolus'd.

• Brand Name: TUOHY EPIDURAL NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): HAKKO CO., LTD; 312 ridgecrest rd.; georgetown TX 78628
• MDR Report Key: 7344698
• MDR Text Key: 102629131
• Report Number: 7344698
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2018,03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/11/2021
• Device Model Number: 6-2150-17
• Device Lot Number: 160311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 146