MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ IV CANNULA; INTRAVASCULAR CATHETER

Catalog Number 391451

Device Problem Leak/Splash (1354)

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

Event Date 06/21/2022

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 in sections manufacturer name, city and state.And mfr site and the (b)(4) fda registration number has been used for the manufacture report number.Investigation summary: there are two samples and one photograph from the customer along with the reported complaint of blood/excess/spills.The investigating team has used the retention samples of material number: 391451 and lot number: 1183775 for investigating the reported defect.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples for blood/excess/spills and no blood/excess/spills was found in the ten retention samples.The received samples were tested for blood/excess/spills and they confirmed that there was leak in the upper port area of the product.The defect is confirmed.This could have occurred due to short cut of silicon valve under the top port that happens due to vibration of the machine causing ipa dosing nozzle to miss the right dose.The dosing nozzle on station 5 & 6 has been re-adjusted for the right dose to fall into the product.Complaints received for this device and reported condition will continue to be tracked and trended.If additional samples are received in the future the complaint will be reopened for further investigation.

Event Description

It was reported while using bd venflon¿ iv cannula after inserting the catheter into a vein, a return of blood was observed through the port.The following information was provided by the initial reporter: after inserting the catheter into a vein, a return of blood was observed through the port, with the opening of the port, the amount of blood increased and a new catheter had to be inserted.

• Brand Name: BD VENFLON¿ IV CANNULA
• 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: karly sambets ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15080722
• MDR Text Key: 304542782
• Report Number: 2243072-2022-00990
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391451
• Device Lot Number: 1183775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2021
• 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