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

Catalog Number 393224

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Exposure to Body Fluids (1745); Hepatitis (1897); Needle Stick/Puncture (2462)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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 a nurse working with the state emergency services received a contaminated needle stick injury while using a bd venflon¿ pro safety shielded iv catheter caused from safety shield activation failure.This needle stick injury allegedly resulted in an infection with (b)(6).There was no report of medical intervention.

Event Description

It was reported that a nurse working with the state emergency services received a contaminated needle stick injury while using a bd venflon¿ pro safety shielded iv catheter caused from safety shield activation failure.This needle stick injury allegedly resulted in an infection with hepatitis c.There was no report of medical intervention.

Manufacturer Narrative

Investigation summary: two photo were returned for investigation.Actual samples were not returned.From the 2 photos, it was observed that the cannula was exposed and not contained within the needle cap safety mechanism.Our quality engineer inspected the returned photos but could not clearly identify the source of the reported defect.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Dhr review revealed no similar complaint received for batch 7262286.No qn raised for the batch.The preventive maintenance, calibration and equipment history records were reviewed and no abnormality was observed.The non-conformance of this complaint could not be determined based on the photo returned.Complaint will be reopened when sample is returned.Complaint trend would be monitored.

• 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
• MDR Report Key: 7622174
• MDR Text Key: 111828304
• Report Number: 8041187-2018-00195
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 393224
• Device Lot Number: 7262286
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other