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

Catalog Number	386860
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter experienced catheter cracked.The following information was provided by the initial reporter: customer used a 24g needle in her l ac.When retracting the needle, customer noticed the catheter bent.User pulled back and got blood return however, they then noticed there was blood coming from the iv site.User once again, pulled the catheter back and thats when user noticed it was the actual catheter that was cracked.When flushing the line the saline was going right through the tubing.Iv was removed and a 22g needle was inserted instead.Patient did notice what was happening, however she states she feels fine and offers no complaints.
Additional Manufacturer Narrative
H3.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 catheter cracked.The following information was provided by the initial reporter: customer used a 24g needle in her l ac.When retracting the needle, customer noticed the catheter bent.User pulled back and got blood return however, they then noticed there was blood coming from the iv site.User once again, pulled the catheter back and that's when user noticed it was the actual catheter that was cracked.When flushing the line the saline was going right through the tubing.Iv was removed and a 22g needle was inserted instead.Patient did notice what was happening, however she states she feels fine and offers no complaints.
Additional Manufacturer Narrative
H.6.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 numbers 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.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.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17646893
• Report Number: 8041187-2023-00462
• Device Sequence Number: 7979168
• Product Code: FOZ
• UDI-Device Identifier: 00382903868605
• UDI-Public: (01)00382903868605
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 09/20/2023

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: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 386860
• Device Lot Number: 2056911
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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