MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO SAFETY SHIELDED IV CATHETER; INTERVASCULAR CATHETER

Catalog Number 393227

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: there was no sample or photo provided to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.A device history record could not be evaluated as the lot number is unknown.Though the incident could not be confirmed based on this complaint, bd is aware of this issue and is in the process of implementing corrective actions to improve the customer and patient experience.This event has been added to our complaint database.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: as no sample and no photo was returned, a review of past 12 months quality notification was performed.No similar quality notification was raised for the reported defect.Based on the verbatim, the probable root cause for the reported condition of this complaint could be due to valve issue that was related to eto sterilization.Capa#1379444 and product recall was initiated for vps product sterilized using eto.However as the batch number is unknown for this complaint, the root cause cannot be confirm.Complaint trend would be monitored.Complaint will be reopened when sample is returned.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter experienced leakage.The following information was provided by the initial reporter: the green 18g bd venflon iv cannula applied on the patient arm started to leak the blood through the valve.Approximately 50ml blood was bled from the patient.It was not noticeable at the time of insertion and fixation with dressings.Upon noticing the bleeding, the cannula removed and replaced with a new cannula.

• Brand Name: BD VENFLON PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR 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: 12104873
• MDR Text Key: 264641194
• Report Number: 8041187-2021-00558
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393227
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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