MAUDE Adverse Event Report: BECTON DICKINSON BD NEOFLON PRO 24GA 0.7MM OD 19MM L; INTRAVASCULAR CATHETER

Catalog Number 391380

Device Problem Break (1069)

Patient Problem Embolism/Embolus (4438)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd neoflon pro 24ga 0.7mm od 19mm l catheter broke and separated the following information was provided by the initial reporter: on (b)(6) 2024 at around 6.20 a.M.During placement of peripheral venous access on left foot (necessary to perform a haemotransfusion of haematology for anaemia) of the little girl born in (b)(6) 2023, a serious malfunction of the device used was verified.After having adequately cannulated the peripheral vein with the catheter ref 391380 bd neoflon pro 24 g, removed the mandrel, viewed slight blood reflux and tested the correct positioning of the access through infusion of a small amount of saline solution, a sudden appearance of a pompho in the proximal site of the catheter was noted, as presumably due to the presence of a proximal structural lesion of the catheter (and not distal, the same as when the catheter is dislocated).Following this, there was verified complete rupture of the catheter, which remained embedded in the vein, making it impossible for the neonatology staff to retrieve it.For the removal of the same, an "incision with removal of the foreign body/device from skin and skin tissue" surgery had to be performed on (b)(6) 2024 (before afternoon).Availability device : yes number of pieces involved : 1 place availability buzzi pharmacy president actions taken: incision with removal of extraneous body/ device from cute and cutaneous tissue consequence: intervention surgical intervention.

Manufacturer Narrative

Correction supplemental for f code.Dhr was reviewed and no abnormality.The manufacturing process has been reviewed and there are no sharp edges that could possibly come into contact with the catheter to cause the cut.There is an automated vision inspection system that can detect and reject product not meeting the lie distance requirement.If the cannula pierce through the catheter or catheter broken in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product will not have any lie distance.It would also not be possible to use the product if the catheter is broken or cannula pierced through the catheter.A simulated sample of cannula piercing through catheter, which is tally with the v-cut on the returned sample.Based on the returned sample, the probable root cause for the reported defect could be due to user partially withdrawn the needle from the catheter and reinserting the needle into the catheter, the needle pierce through the catheter and damage the catheter, and the catheter broken during the removal process eventually.However, we not able to confirm how user handled the product.Complaint trend would be monitored.

Event Description

On (b)(6) 2024 at around 6.20 a.M.During placement of peripheral venous access on left foot (necessary to perform a haemotransfusion of haematology for anaemia) of the little girl born in (b)(6) 2023, a serious malfunction of the device used was verified.After having adequately cannulated the peripheral vein with the catheter ref (b)(4) bd neoflon pro 24 g, removed the mandrel, viewed slight blood reflux and tested the correct positioning of the access through infusion of a small amount of saline solution, a sudden appearance of a pompho in the proximal site of the catheter was noted, as presumably due to the presence of a proximal structural lesion of the catheter (and not distal, the same as when the catheter is dislocated).Following this, there was verified complete rupture of the catheter, which remained embedded in the vein, making it impossible for the neonatology staff to retrieve it.For the removal of the same, an "incision with removal of the foreign body/device from skin and skin tissue" surgery had to be performed on (b)(6) 2024 (before afternoon).Availability device : yes.Number of pieces involved : (b)(4).Place availability (b)(6).Actions taken: incision with removal of extraneous body/ device from cute and cutaneous tissue.Consequence: intervention surgical intervention.

Event Description

On (b)(6) 2024 at around 6.20 a.M.During placement of peripheral venous access on left foot (necessary to perform a haemotransfusion of haematology for anaemia) of the little girl born in (b)(6) 2023, a serious malfunction of the device used was verified.After having adequately cannulated the peripheral vein with the catheter ref 391380 bd neoflon pro 24 g, removed the mandrel, viewed slight blood reflux and tested the correct positioning of the access through infusion of a small amount of saline solution, a sudden appearance of a pompho in the proximal site of the catheter was noted, as presumably due to the presence of a proximal structural lesion of the catheter (and not distal, the same as when the catheter is dislocated).Following this, there was verified complete rupture of the catheter, which remained embedded in the vein, making it impossible for the neonatology staff to retrieve it.For the removal of the same, an "incision with removal of the foreign body/device from skin and skin tissue" surgery had to be performed on (b)(6) 2024 (before afternoon).Availability device : yes.Number of pieces involved : 1.Place availability (b)(6).Actions taken: incision with removal of extraneous body/ device from cute and cutaneous tissue.Consequence: intervention surgical intervention.

Manufacturer Narrative

Dhr was reviewed and no abnormality.The manufacturing process has been reviewed and there are no sharp edges that could possibly come into contact with the catheter to cause the cut.There is an automated vision inspection system that can detect and reject product not meeting the lie distance requirement.If the cannula pierce through the catheter or catheter broken in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product will not have any lie distance.It would also not be possible to use the product if the catheter is broken or cannula pierced through the catheter.A simulated sample of cannula piercing through catheter, which is tally with the v-cut on the returned sample.Based on the returned sample, the probable root cause for the reported defect could be due to user partially withdrawn the needle from the catheter and reinserting the needle into the catheter, the needle pierce through the catheter and damage the catheter, and the catheter broken during the removal process eventually.However, we not able to confirm how user handled the product.Complaint trend would be monitored.

• Brand Name: BD NEOFLON PRO 24GA 0.7MM OD 19MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 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: 18988006
• MDR Text Key: 338727529
• Report Number: 2243072-2024-00450
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903913800
• UDI-Public: (01)00382903913800
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391380
• Device Lot Number: 3052533
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/24/2024; 05/02/2024
• Supplement Dates FDA Received: 04/25/2024; 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention