MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VAMP NEEDLELESS SHIELDED CANNULA; ARTERIAL BLOOD SAMPLING KIT

Model Number VMP400

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  malfunction  

Event Description

It was reported, that a yellow stain like substance was found on the inner surface of cannula before use.The pouch was not opened.There were no patient complications reported.

Manufacturer Narrative

The reported event of yellow stain like substance was found on the inner surface of cannula was confirmed.Unknown yellowish material was observed, at inner surface of vamp cannula housing.The yellowish material was measured approximately 3 x 3 mm in size.The yellowish material was sent to chemistry for further analysis.Per chemistry study, the ir spectrum of the yellowish material was consistent with that of polydimethylsiloxane.Further evaluation regarding related quality issues is under investigation.Complaint histories for all reported events are reviewed, against trending control limits on a monthly basis.And any excursions above the control limits are assessed and documented as a part of the monthly review.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

• Brand Name: VAMP NEEDLELESS SHIELDED CANNULA
• Type of Device: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17322247
• MDR Text Key: 319014741
• Report Number: 2015691-2023-14558
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: VMP400
• Device Catalogue Number: VMP400
• Device Lot Number: 64513890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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