MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 24GX0.75IN STRAIGHT BC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 would not cover the needle.The following information was provided by the initial reporter: this occurred during demonstration.After catheter placement, the hcp retracted the needle but the white component for the safety mechanism stopped halfway and the needle was not retracted completely.
Event or Problem Description
It was reported that cathena 24gx0.75in straight bc safety mechanism would not cover the needle.The following information was provided by the initial reporter: this occurred during demonstration.After catheter placement, the hcp retracted the needle but the white component for the safety mechanism stopped halfway and the needle was not retracted completely.
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received by our quality team for evaluation.Therefore the team is unable to confirm 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.However based on complaints received from other customers, there may have been a dent on the cannula which may have resulted in the safety mechanism device failure.Based on the cannula dent location, the possible contact pont occured 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.H3 other text : see h10.

• Brand Name: CATHENA 24GX0.75IN STRAIGHT BC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11312002
• Report Number: 8041187-2021-00085
• Device Sequence Number: 3711558
• 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?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/10/2021
• 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