MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 20GX1.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Model Number	386803
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 cathena 20gx1.00in straight bc leaked.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "ct manager sent email expressing they are experiencing frequent contrast extravasation events in ct dept.For the most part using 18g for high flow rate injections, test iv's prior to being hooked up to pump.Some ct units are also using 20g for all their injections.".
Additional Manufacturer Narrative
H6: 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.See h.10.
Event or Problem Description
It was reported that the cathena 20gx1.00in straight bc leaked.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "ct manager sent email expressing they are experiencing frequent contrast extravasation events in ct dept.For the most part using 18g for high flow rate injections, test iv's prior to being hooked up to pump.Some ct units are also using 20g for all their injections.".

• Brand Name: CATHENA 20GX1.00IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10668522
• Report Number: 8041187-2020-00668
• Device Sequence Number: 14324085
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: 00382903868032
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201717
• 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): 12/21/2020

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: 386803
• Device Catalogue Number: 386803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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