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

Model Number	386806
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: four photos were received by our quality team for evaluation.From the photos, it was observed that the safety mechanism was not fully activated and there was blood at the needle hub flashback chamber.A device history record review found no non-conformances associated with this issue during production of this batch.As the actual sample was not returned for evaluation, the root cause could not be established.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd cathena¿ safety iv catheter with bd multiguard¿ technology the safety mechanism would not activate.The following information was provided by the initial reporter.The customer stated: "after venipuncture for the patient, the hcp attempted to activate the safety mechanism to retract the needle; however, it didn¿t work and the needle was exposed." there were no reports of injury or medical interventions at this time.
Additional Manufacturer Narrative
Investigation summary: four photos were received by our quality team for evaluation.From the photos, it was observed that the safety mechanism was not fully activated and there was blood at the needle hub flashback chamber.A device history record review found no non-conformances associated with this issue during production of this batch.As the actual sample was not returned for evaluation, the root cause could not be established.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd cathena¿ safety iv catheter with bd multiguard¿ technology the safety mechanism would not activate.The following information was provided by the initial reporter.The customer stated: "after venipuncture for the patient, the hcp attempted to activate the safety mechanism to retract the needle; however, it didn¿t work and the needle was exposed." there were no reports of injury or medical interventions at this time.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY
• 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: 13425512
• Report Number: 8041187-2022-00060
• Device Sequence Number: 12094219
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: 00382903868063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201717
• 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
• Report Date (Section B): 01/25/2022

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 Expiration Date: 07/31/2024
• Device Model Number: 386806
• Device Catalogue Number: 386806
• Device Lot Number: 1207012
• 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: 01/17/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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