MAUDE Adverse Event Report: VYGON SPINAL ANEST NEED; SPINAL ANEST NEED,

Model Number 181.05

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

The review of this batch shows no deviation or non conformity.The spinal needles are compliant to iso 9626.We do not register any complaint on this batch.Nevertheless, the physician should not inserted the stylet after its withdrawal.It seems to be a misuse.We are waiting the involved sample for investigation.

Event Description

A spinal needle code 181.05 of batch 201017an was used for a rachi anesthesia on a (b)(6) patient for a cervical' s hooping.The physician located l3-l4 vertebra for the needle puncture with its stylet.Then, he withdrew the stylet.He was in contact with vertebra, he inserted again the stylet and withdrew the needle.The patient was in position and the physician repeated the same puncture procedure.Again, he was in contact with vertebra , he inserted again the stylet and withdrew the needle.During this withdrawal , the physician noticed that 3,5 cm of the spinal needle was missing.A part of the needle remained in vertebra of the patient.It could not be extracted from the patient.As there is no patient outcome and no functional impairment and no damage, it was decided to wait the birth.

Event Description

A spinal needle code 181.05 of batch 201017an was used for a rachi anesthesia on a 16 amenorrhea weeks pregnant patient for a cervical' s hooping.The physician located l3-l4 vertebra for the needle puncture with its stylet.Then, he withdrew the stylet.He was in contact with vertebra, he inserted again the stylet and withdrew the needle.The patient was in position and the physician repeated the same puncture procedure.Again, he was in contact with vertebra , he inserted again the stylet and withdrew the needle.During this withdrawal , the physician noticed that 3.5 cm of the spinal needle was missing.A part of the needle remained in vertebra of the patient.It could not be extracted from the patient.As there is no patient outcome and no functional impairment and no damage, it was decided to wait the birth.

Manufacturer Narrative

We received the involved sample for investigation.Please find below the investigation: the examination of the sample shows that half of the needle's length is missing.We can notice that the broken extremity is kinked.This is characteristic of an excessive strengths applies to the needle.The contact with vertebra described by the physician is the root cause of this event.The root cause is not linked to a device defect but to its use.The review of this batch shows no deviation or non conformity.The spinal needles are compliant to iso 9626.We do not register any complaint on this batch.

• Brand Name: SPINAL ANEST NEED
• Type of Device: SPINAL ANEST NEED,
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• MDR Report Key: 7995399
• MDR Text Key: 124736990
• Report Number: 2245270-2018-00071
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: K851478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 181.05
• Device Lot Number: 201017AN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention