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

Catalog Number 393224

Device Problems Defective Component (2292); Difficult or Delayed Separation (4044)

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

Event Date 04/01/2022

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 needle in the bd venflon¿ pro safety peripheral safety iv catheter was difficult to disengage during use.The following information was provided by the initial reporter, translated from (b)(6): "during a use of this catheter by the technologist, while trying to remove the mandrel, it got stuck halfway, impossible to take it out completely.The event occurred on friday (b)(6) 2022 at the scanner.There was no risk to the patient because the entire catheter was removed and a new one from the same batch was replaced without any difficulty, which we continue to use.So far, this is only one case because i have not had any other reactions from other technologists.".

Event Description

It was reported that the needle in the bd venflon¿ pro safety peripheral safety iv catheter was difficult to disengage during use.The following information was provided by the initial reporter, translated from french: "during a use of this catheter by the technologist, while trying to remove the mandrel, it got stuck halfway, impossible to take it out completely.The event occurred on friday 01.04.2022 at the scanner.There was no risk to the patient because the entire catheter was removed and a new one from the same batch was replaced without any difficulty, which we continue to use.So far, this is only one case because i have not had any other reactions from other technologists.".

Manufacturer Narrative

The following field was updated due to corrected information: h.6.Imdrf annex a grid: a150302 - difficult or delayed separation.H.6.Investigation: four photos were received by our quality team for evaluation.From the photos, a top web of batch 1323832, a 20g venflon pro safety product in the unit package, and a 20g venflon pro safety cannula and safety mechanism not fully activated from the cannula hub.The tether foil folds on the cannula has correctly formed in a zig-zag fold with no abnormality.However, the reported defect could not be seen clearly from the photos returned.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.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• 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: 14407385
• MDR Text Key: 291717202
• Report Number: 8041187-2022-00251
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 393224
• Device Lot Number: 1323832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2021
• 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