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	07/14/2020
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.(b)(4).
Event or Problem Description
It was reported that blood leaked from the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology during the insertion while removing the needle.This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter: "when introducing the above cathlon into patient¿s vein the plastic cathlon will not move forward causing the vein to blow.On a number of occasions blood flow on insertion when removing the needle occurs.On 13 july a patient was in for a regular infusion and 2 attempts with above was unsuccessful.Used an old cathlon and it went straight in.I find many nurses are attempting a number of starts that fail.This is not safe for patients as well as nursing staff, also time consuming and costly.".
Additional 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 or Problem Description
It was reported that blood leaked from the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology during the insertion while removing the needle.This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter: "when introducing the above cathlon into patient¿s vein the plastic cathlon will not move forward causing the vein to blow.On a number of occasions blood flow on insertion when removing the needle occurs.On 13 july a patient was in for a regular infusion and 2 attempts with above was unsuccessful.Used an old cathlon and it went straight in.I find many nurses are attempting a number of starts that fail.This is not safe for patients as well as nursing staff, also time consuming and costly.".

• 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: 10376669
• Report Number: 8041187-2020-00469
• Device Sequence Number: 2160298
• 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): 08/07/2020

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: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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