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

Model Number	386815
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology was damaged and still operable.There was also blood exposure.The following information was provided by the initial reporter: "the blood-control system of some devices did not work causing the exit of the blood that has smeared the operator exposing him to biological risk.Many times the connection with the cone connector has been made very difficult due to the excessive force to be applied for the secure connection.In a few cases the activation of the safety system caused the twisting of the catheter cannula.In some cases the instaflash system did not work properly making it difficult to access the patient's vein".
Additional Manufacturer Narrative
H.6.Investigation: thirty samples were received by our quality team for evaluation.These samples were subjected to visual inspection, the catheter leak test, the blood escape time test, and the time visualize flashback test.All samples passed these tests and no abnormalities were observed on the returned samples.Therefore, the investigation was not able to confirm what the customer experienced.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 or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology was damaged and still operable.There was also blood exposure.The following information was provided by the initial reporter: "- the blood-control system of some devices did not work causing the exit of the blood that has smeared the operator exposing him to biological risk; - many times the connection with the cone connector has been made very difficult due to the excessive force to be applied for the secure connection; - in a few cases the activation of the safety system caused the twisting of the catheter cannula; - in some cases the instaflash system did not work properly making it difficult to access the patient's vein".

• 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: 10365257
• Report Number: 8041187-2020-00455
• Device Sequence Number: 11476653
• Product Code: FOZ
• UDI-Device Identifier: 00382903868155
• UDI-Public: 00382903868155
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: NA
• 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): 10/20/2020

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: Other
• Device Model Number: 386815
• Device Catalogue Number: 386815
• Device Lot Number: 8269110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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