MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ PRO SAFETY; INTRAVASCULAR CATHETER

Catalog Number 391591

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 08/18/2023

Event Type  Injury  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 while using the bd venflon¿ pro safety adverse event occured without identified device problem.Report 1 of 2.The following was received from the initial reporter: as per discussion on call with nursing superintendent all patients who received venflon i 20g and 22g both has suffered from pain and redness also patient who discharged from hospital, came back to hospital and complained for redness on insertion site.Also asked us to replace existing quantity (count not confirmed yet).

Manufacturer Narrative

No samples (including photos) were returned for the reported issue of ¿irritation/ inflammation¿ with lot number 2248266 regarding item # 391591, so retention samples were used for the investigation.The device history review (dhr) of material number 391591 with lot number 2248266 was checked and there was no quality notification found on this lot number from its production date to its dispatch on date.The investigation and simulation were carried out on performed sterility test result before release the lot # 2248266 where the investigating team has found all results are comply to specification no such type of defect was found in finished goods testing result.The exact root cause can only be determined if we receive the original sample.The root cause cannot be determined.The complaint cannot be investigated further.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Event Description

As per discussion on call with nursing superintendent all patients who received venflon i 20g and 22g both has suffered from pain and redness also patient who discharged from hospital, came back to hospital and complained for redness on insertion site.Also asked us to replace existing quantity (count not confirmed yet).

• Brand Name: BD VENFLON¿ PRO SAFETY
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17691493
• MDR Text Key: 322747099
• Report Number: 2243072-2023-01577
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 391591
• Device Lot Number: 2248266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other