MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L; CATHETER

Catalog Number 393222

Device Problem Retraction Problem (1536)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that venflon pro safety 22ga 0.9mm od 25mm l had a safety mechanism failure and caused a needle stick injury.The following information was provided by the initial reporter: the event or incident happened on (b)(6) 2021 at 23:50 gulf standard time.The reported staff is an emergency room nursing staff.The incident happened whilst cannulating a patient.After inserting the cannula, she removed the stylet.When she removed the stylet, the white part was broken and the film was detached as well.This scenario led to needle stick injury.The incident was right away reported to infection control and quality team.

• Brand Name: VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12017845
• MDR Text Key: 256792572
• Report Number: 8041187-2021-00502
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2021

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: 01/31/2023
• Device Catalogue Number: 393222
• Device Lot Number: 0023711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2020
• 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
• Patient Outcome(s): Other