MAUDE Adverse Event Report: VYGON GMBH PRENICATH; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1261.306

Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008)

Patient Problems Asphyxia (1851); Device Embedded In Tissue or Plaque (3165)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation and investigation.The results of this investigation will be sent to fda in a follow-up mdr with in thirty days of its conclusion.

Event Description

"newborn child suffered from asphyxia, premicath was placed in right vena saphene.Premicath (1261.306) should be removed after 6 days of hospitalization.During this time ""standard mixed solutions with 10 percent amino acids"" and morphine were administered.Heparin was administered before removal of the premicath.After removal of the dressing, customer first pulled the premicath slightly out over the fixation wing and then removed the remaining catheter with ""riffled"" tweezers.When pulling the catheter with tweezers, the catheter was torn off under light traction.About 3-5 cm of remaining catheter have remained in the newborn's body.After a subsequent surgical procedure, the remaining catheter could be removed from the vein.The child is doing well, no further complications have occurred.Additional statement of the senior physician, blood clots were visible in the torn catheter.".

Manufacturer Narrative

For this complaint we received the extravasal part of the premicath, which fragmented at 7 cm.Under the microscope, the fractured surface showed a strongly fissured surface.This indicates a high tensile load when the catheter ruptured.Two photos were taken.The distal catheter fragment was missing, contrary to initial information from the client, and cannot be found.A review of the batch documentation showed that the batch met the specification and was released.The following tests were carried out: tightness and flow test, random sampling test tensile strength, guide movement test, visual checks for completeness, integrity of the sealed seam and contamination.This is the fourth complaint for batch no.280120gn and the 7th complaint regarding this reason for art.No.1261.306.No further corrective action initiated by quality management as there are no hints for a manufacturing fault.

Event Description

Newborn child suffered from asphyxia, premicath was placed in right vena saphene.Premicath (1261.306) should be removed after 6 days of hospitalization.During this time "standard mixed solutions with 10 percent amino acids" and morphine were administered.Heparin was administered before removal of the premicath.After removal of the dressing, customer first pulled the premicath slightly out over the fixation wing and then removed the remaining catheter with "riffled" tweezers.When pulling the catheter with tweezers, the catheter was torn off under light traction.About 3-5 cm of remaining catheter have remained in the newborn's body.After a subsequent surgical procedure, the remaining catheter could be removed from the vein.The child is doing well, no further complications have occurred.Additional statement of the senior physician, blood clots were visible in the torn catheter.

• Brand Name: PRENICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen 52070 ; GM 52070
• MDR Report Key: 10393285
• MDR Text Key: 202586372
• Report Number: 2245270-2020-00072
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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: 1261.306
• Device Lot Number: 280120GN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention