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

Model Number	386815
Medical Device Problem Codes	Difficult to Insert (1316); Defective Component (2292)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 12 of the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology needle insertion was difficult.The following information was provided by the initial reporter: this pediatric patient had 10 iv attempts on the unit and 2 attempts in the or before finally having success obtaining iv access.The cathlons involved were cathena and power port cathlons for ct.Staff on this unit frequently have difficulty with cathena cathlons, many children are suffering the trauma of missed iv access attempts.Impact of incident: patient taken to the or for iv access with sedation.Patient discomfort and likely a traumatic event for this young patient.
Additional Manufacturer Narrative
Correction to initial mdr - a serious injury has been reported without evidence of device malfunction and this complaint is determined to be mdr reportable for serious injury.Annex a code has been updated to a150206 difficult to insert and annex f code f2301 additional device required added.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH WINGS 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17008232
• Report Number: 8041187-2023-00232
• Device Sequence Number: 12480683
• Product Code: FOZ
• UDI-Device Identifier: 00382903868155
• UDI-Public: (01)00382903868155
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2024
• Device Model Number: 386815
• Device Catalogue Number: 386815
• Device Lot Number: 1364232
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown