MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Model Number	386803
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd cathena safety iv catheter the safety mechanism failed and did not deploy.The following information was provided by the initial reporter: functional problem at the level of the safety of the catheter, at the time of the installation of infusion at the time of withdrawing the needle, the safety was not functional: risk of accident of exposure to blood (aes) - bare needle.No accident to report.
Additional Manufacturer Narrative
H.6.Investigation summary: one photo was received by our quality team for evaluation.From the photo, the safety mechanism was observed to not be fully activated and there was blood at the needle hub flashback chamber.A device history record could not be evaluated as the lot number is unknown.From the returned photo, the safety mechanism was observed to be not fully activated and there was blood at the needle hub flashback chamber.However, the team is unable to determine from the photo if there is a dent on the cannula or if there is safety activation components failure / damage that resulted the safety activation failure.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Batch number is unavailable and hence unable to perform the dhr review of the affected batch.As the actual sample was not returned for investigation, actual root cause could not be established.H3 other text : see h10.
Event or Problem Description
It was reported while using bd cathena safety iv catheter the safety mechanism failed and did not deploy.The following information was provided by the initial reporter: functional problem at the level of the safety of the catheter, at the time of the installation of infusion at the time of withdrawing the needle, the safety was not functional: risk of accident of exposure to blood (aes) - bare needle.No accident to report.

• Brand Name: BD CATHENA SAFETY IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13638808
• Report Number: 8041187-2022-00104
• Device Sequence Number: 12021735
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: 00382903868032
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown