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

Catalog Number 391390

Device Problems Break (1069); Air/Gas in Device (4062)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/10/2023

Event Type  Injury  

Event Description

It was reported that the bd neoflon¿ pro iv catheter broke and invasive surgery was performed to remove the broken piece.The following information was provided by the initial reporter: customer complained about sleeving peel back of catheter material in while piercing through skin as well as in vein too.Catheter emblosism also noticed by staff.Additional information received (b)(6)2023: as per discussion with nicu incharge, removed the catheter part by minimally invasive surgery.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers 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.

Event Description

It was reported that the bd neoflon¿ pro iv catheter broke and invasive surgery was performed to remove the broken piece.The following information was provided by the initial reporter: customer complained about sleeving peel back of catheter material in while piercing through skin as well as in vain too.Catheter embolism also noticed by staff.Additional information received 22 may 2023: as per discussion with nicu in charge, removed the catheter part by minimally invasive surgery.

• Brand Name: BD NEOFLON¿ PRO 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17073248
• MDR Text Key: 317669380
• Report Number: 8041187-2023-00253
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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?: Yes
• Device Operator: Other
• Device Catalogue Number: 391390
• Device Lot Number: 2355039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• 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
• Patient Sex: Male