MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 391592

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4), india.This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed in manufacturer name, city and state and mfr site and the (b)(4) fda registration number has been used for the manufacture report number.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 2 bd venflon¿ iv catheter tips were defective.The following information was provided by the initial reporter: "complain on venflon i catheter tip hardness".

Manufacturer Narrative

Follow up mdr for device evaluation: there are no samples and no photograph along with the reported complaint of catheter damage/defective.The investigating team has used the retention samples of material number 391592 and lot number 2160678 for investigating the reported defect.The investigation and simulation were carried out on two retention samples.The investigating team has visually tested the retention samples for catheter damage/defective and no catheter damage/defective was found in the two retention samples.Since there is no samples and no photograph, the defect could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Event Description

No additional information.

• Brand Name: BD VENFLON¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15611393
• MDR Text Key: 307109057
• Report Number: 2243072-2022-01766
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903915927
• UDI-Public: (01)00382903915927
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391592
• Device Lot Number: 2160678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 07/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1