MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO 0.9MM X 25MM; INTRAVASCULAR CATHETER

Catalog Number 393202

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

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 malfunction occurred with a venflon pro 0.9mm x 25mm.The following information was provided by the initial reporter, "the incident occurred in the radiology department in the hospital.The product was placed successful in the patients vein, on the hand.When the nurse should remove the needle from the vialon-catheter, the needle stuck/couldn't get out.She had to remove the whole catheter from the patient.The patient had to get one more needlestick.".

Manufacturer Narrative

H.6.Investigation summary: since no samples or photos displaying the condition reported are available for examination, we were unable to fully verify this incident.A review of the device history record revealed no irregularities during the manufacture of the reported lot.While we were unable to confirmed this report, the nonconformance may have occurred during manufacturing due to the gradual choking of the silicone filter supply line.A preventive maintenance requirement was implemented to check the silicone filter regularly.Additionally, the system alarm for the choking of the filter will be optimized to prevent future occurrences of this type.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants an additional formal corrective action, resources will be assigned at that time.

Event Description

It was reported that a malfunction occurred with a venflon pro 0.9mm x 25mm.The following information was provided by the initial reporter, "the incident occurred in the radiology department in the hospital.The product was placed successful in the patients vein, on the hand.When the nurse should remove the needle from the vialon-catheter, the needle stuck/couldn't get out.She had to remove the whole catheter from the patient.The patient had to get one more needlestick".

• Brand Name: VENFLON PRO 0.9MM X 25MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8701590
• MDR Text Key: 149709196
• Report Number: 8041187-2019-00459
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903932023
• UDI-Public: 382903932023
• 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: 06/25/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 393202
• Device Lot Number: 8108168
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 05/27/2019
• Supplement Dates FDA Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other