MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ I (20GA); INTRAVASCULAR CATHETER

Catalog Number 391592

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: 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 device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd venflon¿ i (20ga) had the catheter split.The following information was provided by the initial reporter: "iv cannula breaks in to two pieces while inserting in to patient.".

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 from lot # 1176777 regarding item # 391592 with the reported issue that ¿iv cannula breaks in to two pieces while inserting into patient¿.The dhr of material number 391592 and lot number 1176777 was checked and no quality notification was recorded on this lot.No sample and one photograph was received from the customer and was used for investigation of the reported defect.The investigation team also used retention samples of material code 391592 and lot number 1176777 for investigating the reported defect of needle breaking on insertion.None of the ten retention samples showed any needle breaking on insertion in them.The photograph of the complaint sample visibly shows needle breaking on insertion.The defect is confirmed.Why did the needle break during insertion? the needle broke during insertion because of wrong practice /handling the product while using it to insert.On simulating the practice of a similar product of the same lot retained by the manufacturing unit, the investigating team found that the product falls apart in the similar manner as observed in the photograph if the nurse slightly tilts the product after it is removed from the unit pack and before she inserts it into the patient.

Event Description

It was reported that bd venflon¿ i (20ga) had the catheter split.The following information was provided by the initial reporter: "iv cannula breaks in to two pieces while inserting in to patient.".

• Brand Name: BD VENFLON¿ I (20GA)
• Type of Device: INTRAVASCULAR 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: 13121677
• MDR Text Key: 283823841
• Report Number: 2243072-2021-03011
• 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: 01/13/2022

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: 391592
• Device Lot Number: 1176777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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