MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) UNSPECIFIED VENFLON PRO¿ SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problems Entrapment of Device (1212); Device Or Device Fragments Location Unknown (2590)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 in (b)(6) 2017 a patient had an unspecified bd venflon pro¿ safety iv catheter removed without issue but was complaining of pain.The patient went home but a few days later was still complaining of pain and went back to see the doctor.The patient was sent for an ultrasound and it was confirmed that a 1-2mm of catheter remained in the patient¿s vessel.The patient was then scheduled to have surgery for removal but when re-scanned the catheter was no longer visible.

Manufacturer Narrative

Investigation results: since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident.No dhr review was performed as the lot number is unknown.No root cause could be determined since no evaluation could be performed.No corrective action is required at this time.

• Brand Name: UNSPECIFIED VENFLON PRO¿ SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7253054
• MDR Text Key: 99548274
• Report Number: 8041187-2018-00042
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention