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

Catalog Number 393228

Device Problems Disconnection (1171); Fitting Problem (2183); Detachment of Device or Device Component (2907)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 shielded iv catheter was difficult to connect to the adapter and separated from it during use.The following information was provided by the initial reporter: "we have been using your venflons for the last weeks in my ambulance service.When there are some indication to prescribe a blood test, we are used to punction a blood sample when we set a intraveinous access.In order to adapt our laboratory samples and the venflon, we use the multi-adapter sarstedt.Since we began to use the venflons that you provide, we had several incidents reported in our critical incidents reporting system.It seems that de adapter and the venflon don¿t match everytime and disconnect one the other.".

Manufacturer Narrative

Corrections: the previously used annex a codes should be disregarded and only the updated code should be considered: h.6.Imdrf annex a grid: a0501.D.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 09-mar-2022.Investigation: h.6.Investigation summary: three used samples and three blood collection adapters from sarstedt were received by our quality team for evaluation.As the blood collection adapters were not manufactured by a bd plant, no further investigation was performed on them.One sample from batch 1176651 (material 393228) was received.The sample was subjected to visual inspection and luer cone measurement.All inspection result passed, and no abnormalities were observed.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 three returned samples were able to connect with the sarstedt adapter properly.As the disconnection was not observed from the returned samples, the customer experience cannot be determined.The probable root cause for the adapter to slip out could be due to the user not fitting the adapter with the cannula hub properly and caused the connection to be loose.The user may consider using a luer lock connector instead of luer slip connector for a more secured connection.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter was difficult to connect to the adapter and separated from it during use.The following information was provided by the initial reporter: "we have been using your venflons for the last weeks in my ambulance service.When there are some indication to prescribe a blood test, we are used to punction a blood sample when we set a intraveinous access.In order to adapt our laboratory samples and the venflon, we use the multi-adapter sarstedt.Since we began to use the venflons that you provide, we had several incidents reported in our critical incidents reporting system.It seems that de adapter and the venflon don¿t match everytime and disconnect one the other.".

• Brand Name: BD VENFLON¿ PRO SAFETY SHIELDED 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: 14055405
• MDR Text Key: 288901552
• Report Number: 8041187-2022-00181
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 393228
• Device Lot Number: 1176651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2021
• 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