MAUDE Adverse Event Report: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Model Number	383335
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 saf-t-intima¿ iv catheter safety system experienced leakage.The following information was provided by the initial reporter: the connection between the flexible catheter and the catheter seat extending from the opaque needle wing is bleeding.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-08-03.H6: investigation summary: bd received one sample submitted for evaluation.The reported issue was confirmed upon inspection of the sample.The catheter was damaged by the needle, which resulted in leakage.This failure can occur in one of our manufacturing processes, but since the sample was used, user error could also cause this failure.Therefore, the root cause cannot be conclusively determined.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.A retraining and alert were issued to all manufacturing personal involved with the procedure associated with this defect.It is recommended that prior to using bd devices the user review the instruction for use documentation to prevent potential failures.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.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system experienced leakage.The following information was provided by the initial reporter: the connection between the flexible catheter and the catheter seat extending from the opaque needle wing is bleeding.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12334557
• Report Number: 9610847-2021-00376
• Device Sequence Number: 16832726
• Product Code: FOZ
• UDI-Device Identifier: 30382903833352
• UDI-Public: 30382903833352
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 11/30/2023
• Device Model Number: 383335
• Device Catalogue Number: 383335
• Device Lot Number: 9326776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2019
• 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