MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS NEOFLON PRO 24GA 0.7MM OD 19MM; INTRAVASCULAR CATHETER

Catalog Number 391380

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

Patient Problems Necrosis (1971); Pain (1994); Phlebitis (2004)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.

Event Description

It was reported that when using bd neoflon pro 24ga 0.7mm od 19mm patient developed necrotic skin.The following information was provided by the initial reporter " this is not a report for one incident, but several incidents over a long period of time.The doctors, who have used neoflon for many years, with great success and liking, are now very frustrated after 7-8 months with neoflon pro.First they thought it was just getting adjusted to the new technique with instaflash, and blamed themselves.Now they do not do that any more, they are just sad and frustrated.They have far more misplacements and have to stick patients many more times than before.They have had more extravasations, more flebitis, more kinking catheters when placing them (mote than the few times they experienced that with neoflon).They feel the needle is the same, but because of the distance between needle and catheter (to make instaflash work), it is harder to be sure the catheter is placed correctly, they penetrate more often and can not check placement the same way as on neoflon, so they have to re-stick.They have the tiniest patients, so this is painful for patient as well as doctors.They have discussed with other neonatal wards, who see the same.Doctor tell us they feel they have been set 30 years back when it comes to cannula placements.We do not know what to reply to this very knowledgeable groups of specialized doctors.Any help will be useful! they have had several extravasations, as they have been used to neoflon being so safe, they have administered quite potent nutrition peripheric.They have stopped doing that now, because of several incidents.They take the blame for administrating omething in a pvc that should have been central, but since these patient are so tiny, they are very restrictive regarding placing central lines.After several extravasations, they have babies with necrosis who needed skin transplants to repair damaged tissue and skin.They have stopped administrating the most potent drugs in the pivc now, and are using other less potent drugs, but that again means less effective treatment to those vulnerable patients who need it the most.".

Manufacturer Narrative

(b)(4).Follow up mdr supplemental for device evaluation.As no sample and no photo were returned, further investigation cannot be performed.No similar quality notification was raised for the reported defect in the past 12 months.Therefore, the root cause cannot be determined.Complaint trend would be monitored, and complaint will be reopened when sample is returned.Recommendation provide training on the proper user handling techniques to all users.

Event Description

No additional information.This is not a report for one incident, but several incidents over a long period of time.The doctors, who have used neoflon for many years, with great success and liking, are now very frustrated after 7-8 months with neoflon pro.First they thought it was just getting adjusted to the new technique with instaflash, and blamed themselves.Now they do not do that any more, they are just sad and frustrated.They have far more misplacements and have to stick patients many more times than before.They have had more extravasations, more flebitis, more kinking catheters when placing them (mote than the few times they experienced that with neoflon).They feel the needle is the same, but because of the distanse between needle and catheter (to make instaflash work), it is harder to be sure the catheter is placed correctly, they penetrate more often and can not check placement the same way as on neoflon, so they have to re-stick.They have the tiniest patients, so this is painful for patient as well as doctors.They have discussed with other neonatal wards, who see the same.Doctor tell us they feel they have been set 30 years back when it comes to cannula placements.We do not know what to reply to this very knowledgeable groups of specialized doctors any help will be useful! update (10/oct/2023): i don¿t understand the first question ¿ please rephrase.Rest in red below.Was the catheter shorter/ longer or was it the needle? can you provide more information on the extravasation? they have had several extravasations, as they have been used to neoflon being so safe, they have administered quite potent nutrition peripheric.They have stopped doing that now, because of several incidents.They take the blame for administrating omething in a pvc that should have been central, but since these patient are so tiny, they are very restrictive regarding placing central lines.Can you provide more information on patient impact for the events? after several extravasations, they have babies with necrosis who needed skin transplants to repair damaged tissue and skin.They have stopped administrating the most potent drugs in the pivc now, and are using other less potent drugs, but that again means less effective treatment to those vulnerable patients who need it the most.

• Brand Name: NEOFLON PRO 24GA 0.7MM OD 19MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17944537
• MDR Text Key: 325801089
• Report Number: 2243072-2023-01872
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903913800
• UDI-Public: (01)00382903913800
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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: 391380
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 10/18/2023
• 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): Required Intervention