MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ NEOFLON PRO SAFETY 24GX0.75IN WINGED; PERIPHERAL VASCULAR CATHETER

Catalog Number	391662
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that there have been ongoing issues with the back flow of bd¿ neoflon pro safety 24gx0.75in winged once the safety device is removed.Healthcare worker exposed to blood.No medical intervention was reported.
Additional Manufacturer Narrative
Investigation: 3 representative samples were returned for evaluation the samples were not decontaminated by vendor.The investigation was not able to confirm what customer had experienced as returned representative samples passed cathena ¿ time to visualize flashback at flash chamber test.A review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance.No abnormality was observed during the production of the reported batch.The investigation was not able to confirm what customer had experienced as returned representative samples passed cathena- time to visualize flashback at flash chamber test.Hence, root cause is unable to be determined.
Event or Problem Description
It was reported that there have been ongoing issues with the back flow of bd¿ neoflon pro safety 24gx0.75in winged once the safety device is removed.Healthcare worker exposed to blood.No medical intervention was reported.

• Brand Name: BD¿ NEOFLON PRO SAFETY 24GX0.75IN WINGED
• Common Device Name: PERIPHERAL VASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8464993
• Report Number: 8041187-2019-00261
• Device Sequence Number: 1436322
• Product Code: FOZ
• UDI-Device Identifier: 00382903916627
• UDI-Public: 00382903916627
• Combination Product (Y/N): N
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 03/31/2021
• Device Catalogue Number: 391662
• Device Lot Number: 8086300
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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