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

Catalog Number 393224

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

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 once the bd venflon¿ pro safety peripheral safety iv catheter had venous return at the valve level and there is a risk for exposure to blood.Found during use.No reports of blood exposure, serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: three representative samples were returned for investigation of this complaint.The three representative samples were subjected to visual inspection of cannula hub, injection valve test, and catheter adapter leak test.All three representative samples passed the acceptance criteria.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7357452.Investigation conclusion: the non-conformance of this complaint could not be determined as all the representative samples passed the acceptance criteria.

• Brand Name: BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7374155
• MDR Text Key: 103679294
• Report Number: 8041187-2018-00073
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 393224
• Device Lot Number: 7357452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other