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

Catalog Number 393224

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).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 after use a bd venflon¿ pro safety shielded iv catheter safety shield activation failed.There was no report of exposure, injury or medical intervention needed.

Event Description

It was reported that after use a bd venflon¿ pro safety shielded iv catheter safety shield activation failed.There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: our quality engineer inspected the two returned photos and observed that the cannula was exposed and not contained within the needle cap safety mechanism.However, since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.However 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 SAFETY SHIELD
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7621606
• MDR Text Key: 112048644
• Report Number: 8041187-2018-00201
• 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: 07/06/2018

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: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 393224
• Device Lot Number: 7142341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other