MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY IV CATHETER 20G; INTRAVENEOUS CATHETER

Catalog Number 393264

Device Problem Insufficient Information (3190)

Patient Problem Phlebitis (2004)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.Suspect medical device; device manufacture date: the exact device used in this incident is unknown.Two potential lot numbers have been provided for the reported catalog number.Lot 5265426, medical device expiration date: 9/30/2018, device manufacture date: 9/22/2015; lot 5030237, medical device expiration date: 1/31/2018, device manufacture date: 1/30/2015.Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.

Event Description

It was reported that at (b)(6), the patient had surgery following phlebitis from the suspect device.Although it is unknown who placed and operated the device, it was reported that the rescue service at the facility places 50% of the vascular access devices.

• Brand Name: BD VENFLON¿ PRO SAFETY IV CATHETER 20G
• Type of Device: INTRAVENEOUS 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5495044
• MDR Text Key: 40158990
• Report Number: 8041187-2016-00016
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 393264
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/11/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention