MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386807
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2021
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.(b)(4).
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter experienced leakage.The following information was provided by the initial reporter: the hcp advanced the catheter and attempted to disengage the needle; however, the needle was not disengaged, resulting in blood leakage.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter experienced leakage.The following information was provided by the initial reporter: the hcp advanced the catheter and attempted to disengage the needle; however, the needle was not disengaged, resulting in blood leakage.
Additional Manufacturer Narrative
Investigation summary : four photos and two samples were received by our quality team for evaluation.From the returned photos and samples, the safety mechanism device was observed to be partially activated, 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.This incident has been added to our database of reported incidents.

• Brand Name: BD CATHENA SAFETY IV CATHETER
• 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: 11298014
• Report Number: 8041187-2021-00076
• Device Sequence Number: 14660487
• 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: Health Professional
• 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: 01/21/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/08/2021
• 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