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

Model Number	386808
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology leaked through the valve.The following information was provided by the initial reporter: "it was reported that: (catheter iv safety winged with multiguard 18gax1.25in cathena)they do not thread after a blood flash has been seen and the valve often leaks.Event description per attached email states: these new catheters are extremely difficult to use.They do not thread after a blood flash has been seen.The failure rate with these catheters is high.The valve often leaks.When attempting to draw labs (especially on pediatric patients) the valve prevents this and results in a second invasive procedure on a child.This is a dramatically inferior product.Questions/inquiries related to 18gax1.25in cathena: no device(s) retained? photos of product? photos of boxes/packaging? incident date? what day was this issue recorded/discovered? is representative sample (unused product from same lot) available?".
Event or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology leaked through the valve.The following information was provided by the initial reporter: "it was reported that: (catheter iv safety winged with multiguard 18gax1.25in cathena)they do not thread after a blood flash has been seen and the valve often leaks.Event description per attached email states: these new catheters are extremely difficult to use.They do not thread after a blood flash has been seen.The failure rate with these catheters is high.The valve often leaks.When attempting to draw labs (especially on pediatric patients) the valve prevents this and results in a second invasive procedure on a child.This is a dramatically inferior product.Questions/inquiries related to 18gax1.25in cathena.-no device(s) retained? photos of product? photos of boxes/packaging? -incident date? what day was this issue recorded/discovered? -is representative sample (unused product from same lot) available?".
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.

• 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: 10274297
• Report Number: 8041187-2020-00403
• Device Sequence Number: 2911945
• Product Code: FOZ
• UDI-Device Identifier: 00382903868087
• UDI-Public: 00382903868087
• 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,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: 386808
• Device Catalogue Number: 386808
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/17/2020
• 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