MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number	386811
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: 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 or Problem Description
It was reported that when disposing the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology needle, blood splashed off the shaft and onto the nurse's face.There was no report of injury or exposure to the mucous membrane.The following information was provided by the initial reporter: "the blood splashed when the needle was being disposed of, as there was blood on the secured needle shaft, which bent while being put in the sharps bin, and it flicked blood on the nurse¿s face.With the exposed needle having blood on it, and the flimsy and unprotected design of the unit, there seems to be a lot of concern and reports about higher risk to staff." "unable to advance catheter, stiff.Blood exposed on open needle.Unable to use iv, new iv required.".
Additional Manufacturer Narrative
H.6.Investigation: 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.H3 other text : see h.10.
Event or Problem Description
It was reported that when disposing the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology needle, blood splashed off the shaft and onto the nurse's face.There was no report of injury or exposure to the mucous membrane.The following information was provided by the initial reporter: "the blood splashed when the needle was being disposed of, as there was blood on the secured needle shaft, which bent while being put in the sharps bin, and it flicked blood on the nurse¿s face.With the exposed needle having blood on it, and the flimsy and unprotected design of the unit, there seems to be a lot of concern and reports about higher risk to staff." "unable to advance catheter, stiff.Blood exposed on open needle.Unable to use iv, new iv required.".

• Brand Name: BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10248636
• Report Number: 8041187-2020-00396
• Device Sequence Number: 13667982
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: 00382903868117
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• 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): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 386811
• Device Catalogue Number: 386811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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