MAUDE Adverse Event Report: VYGON SPINAL ANEST NEED

Model Number 181.05

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

The involved device is not available, it was not kept.The review of this batch shows no deviation or non conformity.The spinal needles are compliant to iso 9626.We do not register any similar complaint on this product code.

Event Description

A spinal needle code 181.05 of batch 220618an was used for a rachi anesthesia on a pregnant obese patient for a caesarean.The introducer was placed ,then the needle and the hub dislodged.The needle was withdrawn and replaced.There is no patient outcome.

• Brand Name: SPINAL ANEST NEED
• Type of Device: SPINAL ANEST NEED
• 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: 8114624
• MDR Text Key: 128720370
• Report Number: 2245270-2018-00089
• 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
• Report Date: 11/27/2018

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 Lot Number: 220618AN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: No
• 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