MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L; INTRAVASCULAR CATHETER

Catalog Number 393224

Device Problem Break (1069)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd venflon pro safety 20ga 1.1mm od 32mm l needle broke the following information was provided by the initial reporter: the nurse pricked the patient to place his iv and when she wanted to remove the needle, it was cut in two.One part came out with the safety and the other part of the needle remained in the catheter.Fortunately, she was able to remove the catheter with the needle tip inside without harm to the patient; except that he had to be stung a second time.

Event Description

The nurse pricked the patient to place his iv and when she wanted to remove the needle, it was cut in two.One part came out with the safety and the other part of the needle remained in the catheter.Fortunately, she was able to remove the catheter with the needle tip inside without harm to the patient; except that he had to be stung a second time.

Manufacturer Narrative

Based on the returned sample, curve edges were observed on the broken edge of the cannula.This suggested that material necking has taken place and likely to be caused by cannula being bent beyond the ultimate strength that the cannula can withstand.This eventually led to broken cannula.The manufacturing process has been reviewed.There is no process in the manufacturing that would cause the cannula to bend to such extent that would break the cannula.In addition, if the needle was bent, it is not possible to assemble the protection tube.Therefore, the reported nonconformance is not caused by the manufacturing process.A simulation was performed to simulate the defect.A vps sample was bent at about 90 degrees in the unit package.The sample was then removed from the package and inspected.Similar defect was replicated.Therefore, the probable root cause for the broken cannula could be due to manipulation of product or inappropriate storage of the product such as over packing the shelf which resulted in product to bend.Dhr was reviewed and no abnormality was reported.No similar quality notification was raised for the reported defect in the past 12 months.Complaint trend would be monitored.

• Brand Name: BD VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L
• 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: 18582559
• MDR Text Key: 334775028
• Report Number: 2243072-2024-00068
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903932245
• UDI-Public: (01)00382903932245
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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: Other
• Device Catalogue Number: 393224
• Device Lot Number: 3137779
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1