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

Model Number	386860
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
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.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter experienced a safety mechanism that would not activate.The following information was provided by the initial reporter: "cathena was not able to safety.".
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter experienced a safety mechanism that would not activate.The following information was provided by the initial reporter: "cathena was not able to safety.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10-aug-2022.H.6.Investigation summary: one photo and one sample with open packaging were received by our quality team for evaluation.From the photo, the safety mechanism was observed to not be activated.The sample was observed with the safety mechanism not activated.The tip shield was manually pushed through the cannula and was able to be activated properly; no safety activation failure was observed.No dent was observed on the cannula.A device history record review found no abnormalities associated with this issue during production of this batch.Based on the evaluation on the returned sample, no dent was observed on the cannula that would obstruct the movement of the tip shield for safety activation.The safety mechanism of the returned sample was able to be manually activated and no safety activation failure was observed.Therefore, 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.H3 other text : see h10.
Additional Manufacturer Narrative
Correction: g.5.Pma / 510(k)#: k220584 h6: investigation summary one photo was received by our quality team for evaluation.From the photo, the safety mechanism was observed to not be activated.A device history record review found no abnormalities associated with this issue during production of this batch.From the photo, the safety mechanism was not activated, however, the team is unable to evaluate from the photo whether there is safety activation components failure or damage that could have resulted in the safety activation failure.As no sample was returned, a root cause could not be established.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter experienced a safety mechanism that would not activate.The following information was provided by the initial reporter: "cathena was not able to safety.".

• 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: 14951487
• Report Number: 8041187-2022-00347
• Device Sequence Number: 15179855
• Product Code: FOZ
• UDI-Device Identifier: 00382903868605
• UDI-Public: 00382903868605
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2022

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: 06/30/2024
• Device Model Number: 386860
• Device Catalogue Number: 386860
• Device Lot Number: 1175157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 10/10/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/24/2022; 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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