MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER

Catalog Number 393224

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified. A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found. Based on the quality team's investigation, the root cause of this incident cannot be determined. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd venflon¿ pro safety peripheral safety iv catheter broke from the hub and remained in the patient. Surgical intervention was needed to remove the broken piece. The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021, the nurse noticed protruding venflon in the patient. After removing the fixing patch, the tip of the venflon was visible and the rest remained in the vessel lumen. " "on the second day after inserting the cannula, the nurse noticed venflon protruding above the patch. It turned out that the cannula is broken. The nurse informed the doctor on duty. Surgical intervention was necessary to remove part of the broken cannula. ".

• 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: 12753730
• MDR Text Key: 280458831
• Report Number: 8041187-2021-00951
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 393224
• Device Lot Number: 1139430
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/04/2021 Patient Sequence Number: 1