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

Catalog Number 393226

Device Problems Retraction Problem (1536); Fail-Safe Did Not Operate (4046)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/11/2022

Event Type  Injury  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1359667.Medical device expiration date: 31-dec-2024.Device manufacture date: 28-jan-2022.Medical device lot #: 2022957.Medical device expiration date: 31-jan-2025.Device manufacture date: 11-feb-2022.Investigation summary: one photo was received by our quality team for evaluation.From the photo, two top webs are observed, one from batch 2022957 and one from batch 1359667.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.As no sample was received, the root cause cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the safety guard on the bd venflon¿ pro safety shielded iv catheter did not cover the needle properly and the user received a dirty needle stick as a result.Blood testing was completed per protocol.This occurred once each in lots 1359667 and 2022957.The following information was provided by the initial reporter: "when i had inserted the pvk and was about to pull out the needle, the safety guard did not go on as they usually do and i did not discover this until i stabbed myself" what i have done is to check the pvk.And took 2 pcs.With different designations.And tested that the protection came out as it should, and both pvk worked.The product is discarded because it has been used and the employee who stabbed himself did not think to save it.The employee follows our routines and has been in contact with the healthcare system for follow-up.

Manufacturer Narrative

After additional review, the following field has been corrected: h.6.Imdrf annex a grid: a0510.

Event Description

It was reported that the safety guard on the bd venflon¿ pro safety shielded iv catheter did not cover the needle properly and the user received a dirty needle stick as a result.Blood testing was completed per protocol.This occurred once each in lots 1359667 and 2022957.The following information was provided by the initial reporter: "when i had inserted the pvk and was about to pull out the needle, the safety guard did not go on as they usually do and i did not discover this until i stabbed myself" what i have done is to check the pvk.And took 2 pcs.With different designations.And tested that the protection came out as it should, and both pvk worked.The product is discarded because it has been used and the employee who stabbed himself did not think to save it.The employee follows our routines and has been in contact with the healthcare system for follow-up.

• Brand Name: BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15373014
• MDR Text Key: 299455758
• Report Number: 8041187-2022-00526
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 09/09/2022

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: 393226
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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