MAUDE Adverse Event Report: VYGON LECTRO-SPIRAL; INTRASVACULAR ADMINISTRATION SET,

Model Number 1159.70

Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Blood Loss (2597); No Code Available (3191); Insufficient Information (4580)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

There were two (2) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2020-00067, 2245270-2020-00068.One failed sample will be returned to vygon for evaluation but the events will be part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of its conclusion.

Event Description

Iv tube leaking due to small hole/crack.

Manufacturer Narrative

There were two (2) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2020-00067 and 2245270-2020-00068.One lectro cath was received used and plugged into an octopus.Analysis of the sample revealed a mark on the tube on the female side and a cut on the male side.The leak test shows a leak at the cut in the tube on the male side.This defect is characteristic of a bending of the tube.It is not recommended to kink the tube or pinch it with forceps / clamp.The defect was reproduced by bending the tube for several hours.A review of the batch file does not show any abnormalities.A 100% tightness control is carried out during manufacture, such a defect would have been detected and rejected automatically.We have not received a similar complaint on this batch and product code over the last 3 years.According to these elements, the cause of the defect is related to the conditions of use.Corrective action: based on the investigation, this issue could not be confirmed; therefore, no further corrective action is initiated at this time.However, both vygon usa and france will continue to monitor this issue.

Event Description

Iv tube leaking due to small hole/crack.

Event Description

Iv tube leaking due to small hole/crack.

Manufacturer Narrative

There were two (2) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2020-00067.2245270-2020-00068.These reports require a correction.Correction: the date of the follow-up report should be 12-oct- 2020.The previous two reports listed 21-jul-2020 erroroneously.

• Brand Name: LECTRO-SPIRAL
• Type of Device: INTRASVACULAR ADMINISTRATION SET,
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 10310211
• MDR Text Key: 199988657
• Report Number: 2245270-2020-00067
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K883612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1159.70
• Device Lot Number: 021118AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 16