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

Model Number	386807
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2020
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.(b)(4).
Event or Problem Description
It was reported that cathena 24gx0.75in straight bc safety mechanism did not work.The following information was provided by the initial reporter: the safety mechanism didn't work.When the customer removed the needle, the needle tip should be covered by push tab.Though after the needle is pulled out , needle tip was not covered by push tab and it was exposed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-28.Investigation summary: one sample was received by our quality team for evaluation.From the returned sample, the safety mechanism device was observed to be partially activated with the needle exposed, confirming the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.A major dent was observed on the cannula of the returned sample.Based on the cannula dent location, the possible contact point occurred at the pick and place station.A simulation was performed and the team was unable to simulate the defect to get the major dent on the cannula as seen in the returned sample.However, it is suspected that the dent on the cannula could be due to a misalignment at the pick and place gripper.A digital angle meter has been implemented at the pick and place station to check the gripper alignment after setup.
Event or Problem Description
It was reported that cathena 24gx0.75in straight bc safety mechanism did not work.The following information was provided by the initial reporter: the safety mechanism didn't work.When the customer removed the needle, the needle tip should be covered by push tab.Though after the needle is pulled out , needle tip was not covered by push tab and it was exposed.

• Brand Name: CATHENA 24GX0.75IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11168105
• Report Number: 8041187-2021-00023
• Device Sequence Number: 3977871
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: 00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/26/2021

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 Expiration Date: 06/30/2022
• Device Model Number: 386807
• Device Catalogue Number: 386807
• Device Lot Number: 9165819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1