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

Catalog Number	386806
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with bd multiguard¿ technology was broken.The following information was provided by the initial reporter, translated from spanish to english: the catheter broke during insertion.During the insertion of the device, when moving the catheter itself over the needle to cannulate it into the vein, without any other manipulation, a resistance was noticed and when the device was removed the plastic tube was broken.
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 with bd multiguard¿ technology was broken.The following information was provided by the initial reporter, translated from spanish to english: the catheter broke during insertion.During the insertion of the device, when moving the catheter itself over the needle to cannulate it into the vein, without any other manipulation, a resistance was noticed and when the device was removed the plastic tube was broken.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 17-aug-2023.H.6.Investigation summary: our quality engineer inspected the 1 photo and 1 used sample submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the samples.Analysis of the sample and photo showed that the needle had pierced through the catheter near the nose of the adapter.It is important to note that blood can also be seen on the catheter, denoting the sample was used.Bd could not determine the cause of the failure since the sample returned was used.If this failure occurred during the manufacturing process, there are systems in place to auto reject defective products.There is a possibility the defect could have occurred during use, but we cannot confirm that cause since we do not know how the product was exactly used.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17484682
• Report Number: 8041187-2023-00412
• Device Sequence Number: 7253629
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: (01)00382903868063
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 09/25/2023

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: Other
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 386806
• Device Lot Number: 2299525
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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