MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON IV CANNULA 20G; INTERVASCULAR CATHETER

Catalog Number 391592

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 08/16/2023

Event Type  Injury  

Event Description

It was reported while using bd venflon iv cannula 20g there was redness and pain.There was no report of patient impact.The following information was provided by the initial reporter: came back to hospital and complained for redness on insertion site.Also asked us to replace existing quantity (count not confirmed yet).

Manufacturer Narrative

The manufacturing location for this product is bawal.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.H6: investigation summary no samples (including photos) were returned for the reported issue of ¿irritation/ inflammation¿ with lot number 3121082 regarding material number 391592, so retention samples were used for the investigation.The device history review (dhr) of material number 391592 with lot number 3121082 was checked and there was no quality notification found on this lot number from its production date to its dispatch on date.A sterility test is performed prior to lot release.The test results for lot number 3121082 were reviewed by the investigating team and it was found that all results are within specification and no defect was found in finished goods testing result.The exact root cause can only be determined if we receive the original sample.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.H3 other text : see h.10.

• Brand Name: BD VENFLON IV CANNULA 20G
• Type of Device: INTERVASCULAR 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17711182
• MDR Text Key: 322961937
• Report Number: 2243072-2023-01596
• 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
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 391592
• Device Lot Number: 3121082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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
• Patient Outcome(s): Required Intervention