MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON PRO SAFETY 20G; INTRAVASCULAR CATHETER

Catalog Number UKN

Device Problem Break (1069)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that bd venflon pro safety 20g needle broke the following information was provided by the initial reporter: my name is (b)(6) and i work as an anaesthesia assistant at the olvg.We are a buyer of the bd venflon pro safety 20g infusion needles.Recently, a report came to the decentralised or reporting committee about these infusion needles.An infusion needle was inserted; and infusion fluid infused over it.However, they felt resistance and then removed the venflon.After removing the venflon, it was found that part of the sharp needle was still in the plastic cannula.So this sharp needle may have broken off during/after insertion.Unfortunately, the package had already been discarded and no batch number was noted.The incident occurred on (b)(6) 2024.Apart from this incident, we have had no other reports of breaking off needles.I was wondering if you may have heard multiple reports of this.Since this could potentially cause serious injury to the patient, i hereby notify you via this email.I have attached the cannula and the broken needle.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

As no sample was returned, further investigation cannot be performed.No similar quality notification was raised for the reported defect in the past 12 months.Therefore, the root cause cannot be determined.Complaint trend would be monitored and complaint will be reopened when sample is returned.

Event Description

My name is (b)(6) and i work as an anaesthesia assistant at the olvg.We are a buyer of the bd venflon pro safety 20g infusion needles.Recently, a report came to the decentralised or reporting committee about these infusion needles.An infusion needle was inserted; and infusion fluid infused over it.However, they felt resistance and then removed the venflon.After removing the venflon, it was found that part of the sharp needle was still in the plastic cannula.So this sharp needle may have broken off during/after insertion.Unfortunately, the package had already been discarded and no batch number was noted.The incident occurred on (b)(6) 2024.Apart from this incident, we have had no other reports of breaking off needles.I was wondering if you may have heard multiple reports of this.Since this could potentially cause serious injury to the patient, i hereby notify you via this email.I have attached the cannula and the broken needle.

• Brand Name: BD VENFLON PRO SAFETY 20G
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18913468
• MDR Text Key: 337774430
• Report Number: 2243072-2024-00286
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: Health Professional
• Device Catalogue Number: UKN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1