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 Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2018

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 during use a bd venflon¿ pro safety peripheral safety iv catheter malfunctioned as "the blood test adapter from sarstedt does not fit into venflon pro safety.The adapter "drops out" when they take a blood test.There was no report of exposure, injury or medical intervention needed.

Event Description

It was reported that during use a bd venflon¿ pro safety peripheral safety iv catheter malfunctioned as "the blood test adapter from sarstedt does not fit into venflon pro safety.The adapter "drops out" when they take a blood test.There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: one actual and one representative sample was returned for investigation.Our quality engineer inspected the returned units and observed lube on the cannula hub of the representative sample.No abnormalities were identified on the actual sample.Both samples passed the iso594 fitting inspection and luer taper measurement test.Therefore, the exact source of the defect could not be determined.A device history record review showed no non-conformances associated with this issue during the production of this batch.The probable root cause could be due lubricant migration to cannula hub which occur with age.The lubrication lowers the friction of interference fit between the luer taper and sarstedt adaptor and could have resulted in the disconnection.There is a capa (capa#(b)(4)) initiated for luer disconnection, this batch is produced before capa action implementation date.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.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted field: device returned to manufacture: yes.

Event Description

It was reported that during use a bd venflon pro safety peripheral safety iv catheter malfunctioned as "the blood test adapter from sarstedt does not fit into venflon pro safety.The adapter "drops out" when they take a blood test.There was no report of exposure, injury or medical intervention needed.

• 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: 7621644
• MDR Text Key: 112434448
• Report Number: 8041187-2018-00212
• 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,Followup
• Report Date: 08/24/2018

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: 10/31/2018
• Device Catalogue Number: 393224
• Device Lot Number: 5294458
• 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