MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO¿ (BD¿ VIALON BIOMATERIAL); INTRAVASCULAR CATHETER

Catalog Number 393204

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem Hematoma (1884)

Event Date 05/15/2018

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 with the use of the bd venflon pro¿ (bd¿ vialon biomaterial) there was an issue with leakage.It was stated ¿the patient had a hematoma.When the device was removed the consumer saw that the needle was through the catheter.There was also leakage of infusion liquid from the hole.Device had to be replaced.¿ there was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd venflon pro¿ (bd¿ vialon biomaterial) there was an issue with leakage.It was stated ¿the patient had a hematoma.When the device was removed the consumer saw that the needle was through the catheter.There was also leakage of infusion liquid from the hole.Device had to be replaced.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: the returned unit was inspected and the reported observation of needle through catheter which caused the reported leakage was confirmed.However, the source of the defect could not be determined.A device history record review showed no non-conformance's associated with this issue during the production of this batch.This reported nonconformance could have occurred out of the manufacturing facilities.There is an automated vision inspection system that rejects parts with this type of defect.Investigation conclusion: the returned sample is different from the catalog reported for this complaint.The root cause will be based on the sample received.There is an automated vision inspection system that rejects part not meeting lie distance requirement.A needle pierce though catheter defect will automatically be rejected as the lie distance will be out of specification.There is no process in the manufacturing facilities that could have caused this nonconformance.Therefore, this reported nonconformance could have occurred out of the manufacturing facilities.

• Brand Name: BD VENFLON PRO¿ (BD¿ VIALON BIOMATERIAL)
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7570985
• MDR Text Key: 110287991
• Report Number: 8041187-2018-00199
• 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
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 393204
• Device Lot Number: 7278487
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other