MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383744

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 12/17/2020

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.(b)(4).

Event Description

It was reported that blood leaked from the bd pegasus¿ safety closed iv catheter system septum during use, and it was found that the part of it was missing at the needle disengagement point.The following information was provided by the initial reporter, translated from (b)(6) to english: "the patient needed to have a ct examination that morning.After the nurse successfully performed a pegasus needle puncture on the patient, when the patient went to the ct room for examination, blood leakage was found at the septum.After a careful observation revealed that the septum was missing" " the sample was contaminated with blood.For safety reasons, the user had discarded it and couldn't return.The defect part of the septum missing was at the needle disengagement point, not at the q-syte end.The blood leakage was happened after puncturing, and it was before the angiography, but the angiography had not performed yet, so there was no influence of high-pressure injection.".

Event Description

It was reported that blood leaked from the bd pegasus¿ safety closed iv catheter system septum during use, and it was found that the part of it was missing at the needle disengagement point.The following information was provided by the initial reporter, translated from chinese to english: "the patient needed to have a ct examination that morning.After the nurse successfully performed a pegasus needle puncture on the patient, when the patient went to the ct room for examination, blood leakage was found at the septum.After a careful observation revealed that the septum was missing" "1.The sample was contaminated with blood.For safety reasons, the user had discarded it and couldn't return 2.The defect part of the septum missing was at the needle disengagement point, not at the q-syte end 3.The blood leakage was happened after puncturing, and it was before the angiography, but the angiography had not performed yet, so there was no influence of high-pressure injection".

Manufacturer Narrative

Investigation summary a device history review was conducted for lot number 0140771.Our records show that this is the only instance of a 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.Based on the provided photograph our engineers were able to observe the missing septum reported to us by the facility.The septum was most likely lost during the course of high pressure injection, which can occur as a result of the manually insertion of the septum into the adapter body.This is currently monitored by the visual inspection of every device prior to packaging; to prevent a reoccurance of this issue we have issued an advisory notice to our inspection teams in order to raise awareness of this kind of non-conformance.

• Brand Name: BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11168282
• MDR Text Key: 227592354
• Report Number: 1710034-2021-00025
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 03/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 383744
• Device Lot Number: 0140771
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1