MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON PRO SAFETY IV CATHETER WITH WINGS 24 GA 0.75 IN; INTERVASCULAR CATHETER

Model Number	391662
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd neoflon pro safety iv catheter with wings 24 ga 0.75 in experienced catheter tip damage/deformation during use.The following information was provided by the initial reporter: for the administration of chemotherapy therapy, we proceed with the positioning of a peripheral venous catheter.We proceed with the detachment procedure (minimum retraction of the spindle and advancement in the initial position) and with venipuncture.Given the presence of blood in the reflux chamber, the mandrel was simultaneously retracted and the catheter was advanced.During this procedure it was pointed out that the catheter was partially cut about one centimeter from the tip.The device was then removed and placed again.
Additional Manufacturer Narrative
H.6.Investigation: eleven representative samples were received by our quality team for evaluation.Upon visual inspection and manual safety activation testing, the samples all passed specifications; therefore, the incident could not be verified.A device history record review found no non-conformance's associated with this issue during production of this batch.Based on the investigation, a probable root cause could not be determined due to the incident not being verified.
Event or Problem Description
It was reported that the bd neoflon pro safety iv catheter with wings 24 ga 0.75 in experienced catheter tip damage/deformation during use.The following information was provided by the initial reporter: for the administration of chemotherapy therapy, we proceed with the positioning of a peripheral venous catheter.We proceed with the detachment procedure (minimum retraction of the spindle and advancement in the initial position) and with venipuncture.Given the presence of blood in the reflux chamber, the mandrel was simultaneously retracted and the catheter was advanced.During this procedure it was pointed out that the catheter was partially cut about one centimeter from the tip.The device was then removed and placed again.

• Brand Name: BD NEOFLON PRO SAFETY IV CATHETER WITH WINGS 24 GA 0.75 IN
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9405288
• Report Number: 8041187-2019-00979
• Device Sequence Number: 16824791
• Product Code: FOZ
• UDI-Device Identifier: 00382903916627
• UDI-Public: 00382903916627
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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
• Operator of Device: Other
• Device Expiration Date: 04/30/2021
• Device Model Number: 391662
• Device Catalogue Number: 391662
• Device Lot Number: 8102375
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other