MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY IV CANNULA WITH INSTAFLASH¿; INTRAVASCULAR CATHETER

Catalog Number 393282

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

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 the bd venflon¿ pro safety iv cannula with instaflash¿ was leaking from the stopper.The following information was provided by the initial reporter: the stopper that comes with the cannula is leaking.Holes right through in the stopper.

Event Description

It was reported that the bd venflon¿ pro safety iv cannula with instaflash¿ was leaking from the stopper.The following information was provided by the initial reporter: the stopper that comes with the cannula is leaking.Holes right through in the stopper.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 2022-06-20.Investigation: h.6.Investigation summary: twelve photos, three used end caps, and thirty-eight representative samples in open packaging of batch 1356889 were received by our quality team for evaluation.The first photo shows a top web of batch 1356889.Photos 2, 3, and 4 show a used end cap contaminated with blood inside unit packaging.Photo 5 shows a shelf carton label of batch 1356889.Photos 6 and 7 show nine unused end caps with cavity side facing up.Photo 8 shows 9 unused end caps with luer cone tip side facing up.A sink mark is observed on all nine end caps luer cone tip.Photo 9 shows one end cap with cavity 29.Photo 10 and 11 shows one end cap observed with a through hole.Photo 12 shows one end cap in opened packaging.The three used end caps were subjected to visual inspection.The end caps were molded from cavity 29, a sink mark and through hole was observed on the luer cone tip of the returned samples.Of the returned representative samples, two end caps were molded from cavity 16, twelve were molded from cavity 17, nine were molded from cavity 29, two were molded from cavity 30, five were molded from cavity 57, seven were molded from cavity 58, and one was molded from cavity 59.All representative samples were subjected to visual inspection.Nine of the 38 samples failed the visual inspection.A sink mark and through hole was observed on the nine end caps luer cone tip.The nine defective end caps were molded form cavity 29.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The probable root cause for the reported leakage could be due to the sink mark hole at the luer cone tip of the end cap.The air vent may be choked during molding and cause hot air to be trapped.This affects the material flow to the final fill area at the luer cone tip.A project has been initiated to address this issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VENFLON¿ PRO SAFETY IV CANNULA WITH INSTAFLASH¿
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14761179
• MDR Text Key: 294595600
• Report Number: 8041187-2022-00322
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393282
• Device Lot Number: 1356889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2022
• 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