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

Catalog Number 383741

Device Problem Detachment Of Device Component (1104)

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

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6) medical university.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the needle detached from the hub of a bd pegasus¿ safety closed iv catheter system w/prn, during use.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation results: a sample was received for the purpose of our investigation.The investigators were able to observe the reported failure mode in the sample provided.The batch record was reviewed, no related abnormalities were found.This device was manufactured on the semi-auto line, during the cannula crimp process the cannula & the paddle hub are joined to prevent separation during use.After this point there is a 100% manual inspection of all completed units, mitigating the likely hood of this failure mode being shipped out to the customer.The most likely root cause is the occurrence of an abnormality at the cannula end crimp station and the subsequent and the operators missing it during the inspection process, as the operators are responsible for identifying and removing any nonconforming material.The inspection process was the subject of an improvement project conducted in october, 2017 which culminated in the addition of an inspection station to help reduce the likelihood of failure occurrence.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM IN. W/PRN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7421838
• MDR Text Key: 105346374
• Report Number: 8041187-2018-00102
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 383741
• Device Lot Number: 7167070
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other