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

Model Number	386818
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
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 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 safety mechanism would not activate and became disengaged when attempting to retract the needle.The following information was provided by the initial reporter, translated from (b)(6) to english: "after inserting the catheter into the patient's vein, the safety system that was supposed to recover the needle became disengaged.The needle could not retract into the system.Proven consequences: absence.Potential consequences: risk of blood exposure accident.Risk of patient injury.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-14.H6: investigation summary : one used sample with open packaging was received by our quality team for evaluation.The safety mechanism was observed to be detached from the user needle and the cannula was bent.Blood stain was observed at the flash chamber.No damage was observed on the washer and tip shield and the cannula was observed to be bent at the notch area.A device history record review found no non-conformances associated with this issue during production of this batch.One similar quality notification was raised in the past 12 months on this reported defect.The root cause was a loosened screw causing misalignment during the cannula insertion to hub process and resulted on a dent on the cannula.Checking of any loosened, wear and tear on the screw will be added to the preventative maintenance task list and the safety activation inspection will be added into in-process inspection form.From the returned sample, the safety mechanism was observed to be detached from the used needle, and the cannula was bent at the notch area.A simulation was performed and the washer, which is the key component to secure the tip shield to the needle, was able to sit properly in the designated slot in the tip shield.However, since the needle was bent at the notch area, a complete simulation was not able to be performed to investigate if the tip shield with the washer assembly was able to be secured on the needle properly without detaching to cover the cannula tip.Therefore, the root cause could not be determined.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.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter safety mechanism would not activate and became disengaged when attempting to retract the needle.The following information was provided by the initial reporter, translated from french to english: "after inserting the catheter into the patient's vein, the safety system that was supposed to recover the needle became disengaged.The needle could not retract into the system.Proven consequences: absence.Potential consequences: risk of blood exposure accident.Risk of patient injury.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12485009
• Report Number: 8041187-2021-00847
• Device Sequence Number: 11696626
• Product Code: FOZ
• UDI-Device Identifier: 00382903868186
• UDI-Public: 00382903868186
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 10/29/2021

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: 03/31/2023
• Device Model Number: 386818
• Device Catalogue Number: 386818
• Device Lot Number: 0098691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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