MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383751

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

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 needle "couldn't remove" correctly after the puncture.There was no report of exposure, injury, or medical intervention.

Event Description

It was reported that the bd pegasus safety closed iv catheter system needle "couldn't remove" correctly after the puncture.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

A device history report was conducted for lot number 7321500, and no related abnormalities were found.This lot of pegasus 24 gauge was manufactured from 11/3/2017-11/7/2017, and this is the only instance of a safety shield activation failure occurring in this lot.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Samples were submitted for evaluation; bd engineers were able to observe a tilted v-clip during the visual observation of the device.The root cause for this occurrence is the design of this component.Since the manufacture of this lot bd has optimized the design to prevent events such as this from occurring in the future.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8026728
• MDR Text Key: 125924042
• Report Number: 8041187-2018-00405
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 383751
• Device Lot Number: 7321500
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other