MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA 24GX0.75IN STRAIGHT; INTRAVASCULAR CATHETER

Model Number	386818
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
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 when using the bd catheter 24gx0.75in straight, the device experienced leakage.The following information was provided by the initial reporter.The customer stated: an extension tube was fitted to the catheter to allow an injection to be made if necessary.The operator checked that the extension was secure as she had previous experience of leakage.When injecting antibiotics, the syringe pump sounds the occlusion.Check of the catheter: leakage around the extension tube which had unscrewed and the catheter was obstructed.(event).
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported when using the bd cathena 24gx0.75in straight, the device experienced leakage.The following information was provided by the initial reporter.The customer stated: an extension tube was fitted to the catheter to allow an injection to be made if necessary.The operator checked that the extension was secure as she had had previous experience of leakage.When injecting antibiotics, the syringe pump sounds the occlusion.Check of the catheter: leakage around the extension tube which had unscrewed and the catheter was obstructed.(event#2).

• Brand Name: BD CATHENA 24GX0.75IN STRAIGHT
• 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: 12442334
• Report Number: 8041187-2021-00815
• Device Sequence Number: 17347249
• Product Code: FOZ
• UDI-Device Identifier: 00382903868186
• UDI-Public: 00382903868186
• 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): 10/14/2021

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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