MAUDE Adverse Event Report: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383911

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system experienced leakage.The following information was provided by the initial reporter: after successful puncture, there was fluid leakage in the place of the catheter.The feedback from the head nurse was that after successful puncture, there was fluid leakage in the connection between the catheter tube and the catheter hub, and then the indwelling needle was removed from the patient's vein.Because of residual blood, the head nurse sealed the sample with a single outer package.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 7/29/2021.H6: investigation: a device history review was conducted for lot number 1050742.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, the submitted sample has been reviewed by our team of quality engineers.Based on microscopic analysis of the sample, our engineers were able to identify damage near the base of the catheter tubing that is consistent with damage that can be sustained during assembly.The root cause for the observed damage is related to operator error during the manual insertion of the cannula.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system experienced leakage.The following information was provided by the initial reporter: after successful puncture, there was fluid leakage in the place of the catheter.The feedback from the head nurse was that after successful puncture, there was fluid leakage in the connection between the catheter tube and the catheter hub, and then the indwelling needle was removed from the patient's vein.Because of residual blood, the head nurse sealed the sample with a single outer package.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12351742
• MDR Text Key: 267592140
• Report Number: 3014704491-2021-00091
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

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 Operator: Other
• Device Expiration Date: 03/07/2024
• Device Catalogue Number: 383911
• Device Lot Number: 1050742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• 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