MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ I 22GA 0.8 MM X 25MM; CATHETER

Catalog Number 391591

Device Problems Break (1069); Product Quality Problem (1506); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.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.Investigation summary: customer returned photographs are available for investigation.Customer photographs were investigated along with the lot number 18g2641e and material number 391592 and we found that the product is venflon i.Venflon i is a new improved design of our previous product venflon.The customer mistook the new product of venflon i as a venflon and thus concluded the improved design as product defect.Our sales associates have met the consultant and educated him on the improved product and its advantages in his area of expertise.Thus the defect is not confirmed.Investigation conclusion: conclusion(s): customer return photographs are available for investigation.Customer photographs were investigated along with the lot no.18g2641e and material no.391592 and we found that the product is venflon i.Venflon i is a new improved design of our previous product venflon.The customer mistook the new product of venflon i as a venflon and thus concluded the improved design as product defect.Root cause description: customer returned photographs are available for investigation.Customer photographs were investigated along with the lot number 18g2641e and material number 391592 and we found that the product is venflon i.Venflon i is a new improved design of our previous product venflon.The customer mistook the new product of venflon i as a venflon and thus concluded the improved design as product defect.Our sales associates have met the consultant and educated him on the improved product and its advantages in his area of expertise.Thus the defect is not confirmed.

Event Description

It was reported that a bd venflon¿ i 22ga 0.8 mm x 25mm was defective.The report is as follows, "the venflon we have been using a very long time.I found you are manufacturing defect ones now, pls look into it.Defective piece can break and enter the blood stream.".

• Brand Name: BD VENFLON¿ I 22GA 0.8 MM X 25MM
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8400173
• MDR Text Key: 139220019
• Report Number: 2243072-2019-00431
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00382903915910
• UDI-Public: 382903915910
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 391591
• Device Lot Number: 18G1141J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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