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

Catalog Number 391455

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is bawal, india.This site is not registered with the fda.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that seal on 150 bd venflon¿ iv cannulas' packaging units were damaged and warped.The following information was provided by the initial reporter: "packaging is warped and seal is compromised.".

Event Description

It was reported that seal on 150 bd venflon¿ iv cannulas' packaging units were damaged and warped.The following information was provided by the initial reporter: "packaging is warped and seal is compromised".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 18-apr-2023.150 samples and 2 photos were received by bd for evaluation.A quality engineer was able to review the pictures and inspect the returned samples for the reported issue of package seal integrity poor / questionable lot number 1363234 and material number 391455.The investigating team has also used the retention samples of lot number 1363234 and material number 391455 for investigating the reported defect.The investigation and simulation were carried out on 25 retention samples where the investigating team has visually checked the samples for package seal integrity poor / questionable and no package seal integrity poor / questionable was found in the 25 retention samples.Investigating team also reviewed the sterilization record, all parameters are found within specification.The original samples were used to investigate the complaint of package seal integrity poor / questionable and it was found that the sample shows defect of package seal integrity poor / questionable in it.The complaint is confirmed.The exact root cause could not be determined.H3 other text : see h10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16714364
• MDR Text Key: 313639580
• Report Number: 2243072-2023-00587
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391455
• Device Lot Number: 1363234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2021
• 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