MAUDE Adverse Event Report: VYGON SPINAL NEEDLE

Model Number 181.05

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

Patient Problems Hemorrhage/Bleeding (1888); Device Embedded In Tissue or Plaque (3165)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

First investigation result: the review of this batch shows no deviation or non conformity.The spinal needles are compliant to iso (b)(4).We do not register any complaint on this batch manufactured this year.Vygon are waiting for more information concerning the anesthesia (could the rachi anesthesia be done or not ?) and the involved sample , was it kept?.

Event Description

A spinal needle code 181.05 of batch (b)(4) was used for an emergency rachi anesthesia on a patient with post-partum hemorrhage for an uterine evacuation examination.This patient moved during the puncture which was very difficult to perform.During the withdrawal of the needle and its stylet, the physician noticed that half of the spinal needle was missing.A part of the needle remained in yellow ligament of the patient.It was extracted from the patient under anesthesia by surgical intervention.No patient outcome remained, there is no permanent damage.

Manufacturer Narrative

The rachi anesthesia could be done.The spinal broke during it withdrawal.The stylet has not been sent back.Therefore , we do not known if it has been used as required.The examination of the sample shows that the whiteacre bevel has not been damaged but the needle is bent and broken at 35 mm from its bevel.See pictures below: this is characteristic of an excessive strength applies to the needle's tube during it use or it withdrawal.The dimension of this needle is compliant to its specification.The root cause of this event is not linked to the device but to its very difficult condition of use.The patient moved during the puncture.

Event Description

A spinal needle code 181.05 of batch 030217an was used for an emergency rachi anesthesia on a patient with post-partum hemorrhage for an uterine evacuation examination.This patient moved during the puncture which was very difficult to perform.During the withdrawal of the needle and its stylet, the physician noticed that half of the spinal needle was missing.A part of the needle remained in yellow ligament of the patient.It was extracted from the patient under anesthesia by surgical intervention.No patient outcome remained, there is no permanent damage.

Manufacturer Narrative

This mdr was initially sent under number 2245270-2017-00061 on (b)(6) 2017.These reports require a correction.Correction: the product lot number associated with the complaint should be (b)(6).The previous two reports listed 041215em erroneously.

• Brand Name: SPINAL NEEDLE
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer (Section G): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 7041788
• MDR Text Key: 92458630
• Report Number: 2245270-2017-00061
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K851478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2018

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 Catalogue Number: 181.05
• Device Lot Number: 030217AN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 11/15/2017; 11/15/2017
• Supplement Dates FDA Received: 01/11/2018; 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention