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

Catalog Number 393226

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that upon removal catheter broke apart and remained in vein and needed to be surgically removed with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: (1 of 2 complaints).To remove the venous catheter, the patch was loosened from the skin, the outer part of the venous catheter fell off and the tube (catheter), which lies in the vascular system, remained in the vein and had to be surgically removed.

Manufacturer Narrative

H.6.Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.

Event Description

It was reported that upon removal catheter broke apart and remained in vein and needed to be surgically removed with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter, translated from german to english: (1 of 2 complaints) to remove the venous catheter, the patch was loosened from the skin, the outer part of the venous catheter fell off and the tube (catheter), which lies in the vascular system, remained in the vein and had to be surgically removed.

• 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
• MDR Report Key: 10074844
• MDR Text Key: 191561945
• Report Number: 8041187-2020-00278
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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: 393226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 04/30/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention