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

Model Number E6-2150-17

Device Problems Fracture (1260); Patient-Device Incompatibility (2682)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

The subject device was not made available because it have not returned from clinic and no more information are available from them.We had the performance test to prove to not break a needle cannula using same manufactured lot device and latest manufactured lot devices (17g tuohy) as attached test reports.As a conclusion,we have not found any problem and also subjective needle cannula might be no problem.

Event Description

Describe the event or problem: 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 chloraprep 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 15cm, 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it was no more than had been experienced during previous epidural placements in other patients.As the needle was being withdrawn to re-direct and attempt a third pass, a sudden loss of resistance was noted and 6 cm of needle was withdrawn, leaving approximately 9cm of needle inside the body of the patient.An emergency consult from general surgery was obtained and a decision was made to move the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 o.R 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 o.R 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.What was the original intended procedure? : epidural placement during labor what problem did the user have (check all that apply}: device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: TUOHY EPIDURAL NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): HAKKO CO.,LTD.; no. 3055 o-aza toguraonsen; chikuma-shi, nagano 38908 07; JA 3890807
• Manufacturer (Section G): HAKKO CO., LTD.; 1490 o-aza isobe; chikuma-shi, nagano 38908 06; JA 3890806
• Manufacturer Contact: masanori yamagishi ; no. 3055 o-aza toguraonsen; chikuma-shi, nagano 389-0-807 ; JA 389-0807
• MDR Report Key: 7445861
• MDR Text Key: 106010794
• Report Number: 3002807220-2018-00001
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04526737171098
• UDI-Public: 04526737171098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Model Number: E6-2150-17
• Device Catalogue Number: 6-2150-17
• Device Lot Number: 160311
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 146