MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 24GX0.75IN STRAIGHT; INTERVASCULAR CATHETER

Catalog Number	386818
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 100 cathena 24gx0.75in straight experienced leakage during use.The following information was provided by the initial reporter: hub is missing the blood control mechanism resulting in blood spill.
Additional Manufacturer Narrative
This complaint has been identified as an ordering error, and not a device malfunction.The incorrect device was ordered/received by the customer.Customer expressed concern when the device they received did not behave like the device they intended to order, though there were no device malfunctions involved.
Event or Problem Description
It was reported that 100 cathena 24gx0.75in straight experienced leakage during use.The following information was provided by the initial reporter: hub is missing the blood control mechanism resulting in blood spill.

• Brand Name: CATHENA 24GX0.75IN STRAIGHT
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8894830
• Report Number: 8041187-2019-00636
• Device Sequence Number: 11445838
• Product Code: FOZ
• UDI-Device Identifier: 00382903868186
• UDI-Public: 00382903868186
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N/A
• 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): 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 386818
• Device Lot Number: 8044069
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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