MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER; UMBILICAL CATHETER,

Model Number 1270.03

Device Problems Device Markings/Labelling Problem (2911); Inaccurate Information (4051); Unclear Information (4052)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

The failed sample will be returned to vygon and will be evaluated as part of the complaint investigation.The results of this investigation are still pending and will be communicated with fda within 30 days of completion.

Event Description

Np had measured baby to insert umbilical catheter, when she inserted the umbilical catheter she looked at the markings and realized immediately that the catheter markings were incorrect.Normally the umbilical catheter markings start with the number 4, whereas this umbilical catheter started with the number 25, which indicated that the markings were incorrect.The np had to removed the umbilical catheter immediately and clamp the baby's umbilical cord until the staff had prepared and primed another umbilical catheter for her to use.

Manufacturer Narrative

The complaint was forwarded to our parent company in france for their evaluation.The investigation summary is as follows: we received one sample for this complaint.Visual examination of the involved sample confirms that the marking is inverted.This means that the defect is manufacturing related.Such kind of defect should have been detected during the manufacturing process and its 100% controls.This failure may be attributed to the lack of vigilance of production operators, who have been alerted to the oversight.In addition, we have taken steps to improve our manufacturing process by reinforcing controls at each step to avoid such kind of defects in the future.A 3 -year historical data review shows that this is an isolated case of this batch and reference.Corrective action: based on the investigation, vygon france production operators have been alerted and this is considered an isolated incident.Both vygon usa and france will continue to monitor this issue.

Event Description

Np had measured baby to insert umbilical catheter, when she inserted the umbilical catheter she looked at the markings and realized immediately that the catheter markings were incorrect.Normally the umbilical catheter markings start with the number 4, whereas this umbilical catheter started with the number 25, which indicated that the markings were incorrect.The np had to removed the umbilical catheter immediately and clamp the baby's umbilical cord until the staff had prepared and primed another umbilical catheter for her to use.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL CATHETER,
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 10656206
• MDR Text Key: 210640907
• Report Number: 2245270-2020-00087
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K921352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1270.03
• Device Catalogue Number: 1270.03
• Device Lot Number: 110119EL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 1