MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 18GX1.25IN WINGED BC; INTRAVASCULAR CATHETER

Model Number	386808
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2020
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 the saline flush was difficult to attach to the cathena 18gx1.25in winged bc during use.The following information was provided by the initial reporter: "very hard to thread.Difficult to attach saline flush.Hard to see flash.Hard to use.".
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.Though an investigation by the manufacturing plant could not be done, sales and marketing did reach out to the customer.During the discussion, it was concluded that there was a lack of understanding of the new product due to lack of training provided.This is a result of covid-19 as they were not allowed to enter the hospital.
Event or Problem Description
It was reported that the saline flush was difficult to attach to to the cathena 18gx1.25in winged bc during use.The following information was provided by the initial reporter: "very hard to thread.Difficult to attach saline flush.Hard to see flash.Hard to use.".

• Brand Name: CATHENA 18GX1.25IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10107504
• Report Number: 8041187-2020-00302
• Device Sequence Number: 17053151
• 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,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/09/2020
• 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