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

Catalog Number 391592

Device Problem Break (1069)

Patient Problem Foreign Body Embolism (4439)

Event Date 02/03/2023

Event Type  Injury  

Event Description

It was reported that 50 of the bd venflon iv cannula 20g broke when being removed from left forearm vein causing left forearm tenderness.The following information was provided by the initial reporter: there was a breakage in bd venflon i iv cannula when it was being removed from the left forearm vein."during period 2 , post dose 24hrs iv cannula removal it was noted by our clinical staff that cannula catheter was not visible and subject was complaining of pain at iv cannula site." "local examination: left forearm: tenderness + at iv cannulation site, cord like thickening felt at iv cannulation site.Subject was reassured and shifted to higher health centre for further evaluation and management.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Oem manufacturer: the manufacturing location for this product is bawal, india.This site is not registered with the fda.Therefore, bd corporate headquarters in franklin lakes, nj has been listed.And the franklin lakes fda registration number has been used for the manufacture report number.

Manufacturer Narrative

The following fields were updated due to additional information: a1: age at time of event 35.A1: age unit: year (=> 3 years).A2: sex: male.D10: device available for eval yes.D10: returned to manufacturer on: 27-feb-2023.H6: investigation summary: 11 samples and no photos were received by bd for evaluation.A quality engineer was able to inspect the returned samples for the reported issue of broken catheter from lot # 2334024 material # 391592.The device history review of material #391592 and batch #2334024 was checked and there were no quality notifications found on this lot number from its production date to its dispatch on date.The investigating team has also used the retention samples of lot # 2334024 material # 391592 for investigating the reported defect.The investigation and simulation were carried out on 10 retention samples and 05 returned samples where the investigating team has functionally (catheter pull force) tested the samples for broken catheter.No catheter broken (out of specification) was found in the 01 retention sample and 05 returned samples.The original contaminated sample was used to investigate the complaint of broken catheter and it was found that the sample shows the defect of broken catheter.The probable root cause of catheter broke / separated can be due to low pull force of the catheter assembly.But it can also be due to practice issue by the nursing staff as it can also be separated / broke if sharp object is used to cut the catheter.As per the original sample received, through the smart scope, 2 photographs were taken.On careful examination, it appears that the broken catheter issue is due to a cut by a sharp object as there is cut in the tip of the catheter from where it is detached.This type of defect could not be replicated on machine & the tensile strength of the material of the catheter is such that it cannot break so easily manually.H3 other text : see h10.

Event Description

It was reported that 50 of the bd venflon iv cannula 20g broke when being removed from left forearm vein causing left forearm tenderness.The following information was provided by the initial reporter: there was a breakage in bd venflon i iv cannula when it was being removed from the left forearm vein."during period 2 , post dose 24hrs iv cannula removal it was noted by our clinical staff that cannula catheter was not visible and subject was complaining of pain at iv cannula site." "local examination: left forearm: tenderness + at iv cannulation site, cord like thickening felt at iv cannulation site.Subject was reassured and shifted to higher health centre for further evaluation and management.

• Brand Name: BD VENFLON IV CANNULA 20G
• Type of Device: INTRAVENOUS 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 ; 8448235433
• MDR Report Key: 16533349
• MDR Text Key: 311211682
• Report Number: 2243072-2023-00384
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391592
• Device Lot Number: 2334024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male