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

Catalog Number 391592

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Phlebitis (2004)

Event Date 02/19/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd venflon iv cannula 20g the needle went through the catheter during use.This led to an increased duration for patient's stay in hospital.There was no report of patient impact.The following information was provided by the initial reporter: when drs tries to increase catheter went down.

Manufacturer Narrative

H.6.Investigation: the photo was received by bd for evaluation.A quality engineer was able to review the photo of a venflon i 20ga 1.0 mm x 32mm from lot # 1148772 regarding item # 391592 with the reported issue of ¿damaged catheter/peelback¿.The investigating team has also used the retention samples of from lot # 1148772 regarding item # 391592 for investigating the reported defect.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples and no damaged catheter/peelback was found.Based on the photograph this is not a peelback issue.The defect is confirmed for catheter damage.No further investigation is possible as the original sample is not available.The root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported while using bd venflon iv cannula 20g the needle went through the catheter during use.This led to an increased duration for patient's stay in hospital.There was no report of patient impact.The following information was provided by the initial reporter: when drs tries to increate catheter went down.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13659167
• MDR Text Key: 286950256
• Report Number: 2243072-2022-00300
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391592
• Device Lot Number: 1148772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• 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): Other