MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER; INTRAVASCUALR CATHETER

Catalog Number 393224

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd venflon pro safety venous indwelling catheter the catheter separated from the hub and remained in patient's arm.The following information was provided by the initial reporter: we hereby report an incident which occurred on or around 07/06.Defective material, a piece of material was found left in the patient's arm.There were no special complications with this patient, such as agitation.Upon inspection, it appeared that a piece of the plastic cannula was missing when the venipuncture was removed.Reported to the direction of the registrar, um, assistant physician, neurologist, vascular surgeon in the icu who decided to perform an arm ultrasound and possibly a ct scan.

Event Description

It was reported while using bd venflon pro safety safety venous indwelling catheter the catheter separated from the hub and remained in patient's arm.The following information was provided by the initial reporter: we hereby report an incident which occurred on or around 07/06 - defective material, a piece of material was found left in the patient's arm.There were no special complications with this patient, such as agitation.Upon inspection, it appeared that a piece of the plastic cannula was missing when the venipuncture was removed.Reported to the direction of the registrar, um, assistant physician, neurologist, vascular surgeon in the icu who decided to perform an arm ultrasound and possibly a ct scan.

Manufacturer Narrative

Correction: imdrf annex a grid a0401 break the following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 21-jul-2022 h6: investigation summary one used sample was received by our quality team for evaluation.The adapter does not belong to the reported complaint and no further investigation was performed on it.The used sample was subjected to visual inspection.A clean cut was observed on the used sample on the broken end of the catheter.From the broken edge, no stretched phenomenon or elongation of the catheter tubing can be observed to indicate any issue with the tubing material which could have caused the breakage.A device history record could not be evaluated as the lot number is unknown.The manufacturing process was reviewed and there are no sharp edges that could possibly come into contact with the catheter to cause the cut.There is an automated vision inspection system that can detect and reject product not meeting the lie distance requirement.If the catheter is broken in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product will not have any lie distance.It would not be possible to use the product if the catheter is broken before use.The probable root cause for the broken catheter could be due to the catheter being cut by a sharp object such as scissors during product removal from vein.It is stated in the instructions for use: ¿do not use scissors at or close to the insertion site¿.However, it is not possible to confirm how the product has been used.

• Brand Name: BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER
• Type of Device: INTRAVASCUALR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15005563
• MDR Text Key: 295860907
• Report Number: 8041187-2022-00365
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 393224
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention