MAUDE Adverse Event Report: VYGON RAMP 4 1WAY S/C+50CM EXT 25C; INFUSION LINE MANIFOLD

Model Number 873.04

Device Problems Break (1069); Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

Iv medications were infusing through a manifold as is usual practice from the or.Bedside rn was not able to unscrew tubing connected to the manifold which prevented the placement of a needleless cap and curios cap.During the attempt to unscrew with tubing, the manifold port broke off.The bedside rn had to complete a partial drip change to remove the manifold from the tubing.

Manufacturer Narrative

This malfunction was first reported to fda by the customer via medwatch (b)(4).The results of this investigation are still pending,and will be communicated to fda within 30 days of its conclusion.

Manufacturer Narrative

This malfunction was first reported to fda by the customer via medwatch (b)(4).The complaint was forwarded to our parent company in france for their evaluation.The investigation summary is as follows: we did not receive a sample for investigation.Without a sample, it is difficult to determine the exact source of this complaint.A review of the batch record shows no anomalies during manufacturing.We performed tests on samples from another batch and found no defects.We have not recorded any similar complaints with this code in the last 3 years.Due to the missing sample, we cannot determine the source of this complaint.Therefore, the root cause of this complaint could not be determined.Corrective action: no further corrective action was initiated by quality management due to the missing sample and the root cause could not be determined.However, both vygon usa and france will continue to monitor this issue.

Event Description

Iv medications were infusing through a manifold as is usual practice from the or.Bedside rn was not able to unscrew tubing connected to the manifold which prevented the placement of a needleless cap and curios cap.During the attempt to unscrew with tubing, the manifold port broke off.The bedside rn had to complete a partial drip change to remove the manifold from the tubing.

• Brand Name: RAMP 4 1WAY S/C+50CM EXT 25C
• Type of Device: INFUSION LINE MANIFOLD
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• Manufacturer (Section G): VYGON; 5 rue adeline; ecouen PA 95440 ; FR 95440
• Manufacturer Contact: freda o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 15012933
• MDR Text Key: 295911130
• Report Number: 2245270-2022-00064
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 873.04
• Device Catalogue Number: 00087304
• Device Lot Number: 300721AH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 70 YR
• Patient Sex: Female