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

Model Number	383335
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
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¿ safety system with removable prn broke at the root of the extension tubing during use while withdrawing the needle.The following information was provided by the initial reporter, translated from chinese to english: "the nurse was preparing to perform a venipuncture on the patient.The root of the extension tube broke and blood was exposed during the withdrawal the needle.".
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photo submitted for evaluation.The reported issue was confirmed upon inspection of the photo.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.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.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd saf-t-intima¿ safety system with removable prn broke at the root of the extension tubing during use while withdrawing the needle.The following information was provided by the initial reporter, translated from chinese to english: "the nurse was preparing to perform a venipuncture on the patient.The root of the extension tube broke and blood was exposed during the withdrawal the needle.".

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12421951
• Report Number: 9610847-2021-00415
• Device Sequence Number: 3254979
• 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): 09/10/2021

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: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 383335
• Device Catalogue Number: 383335
• Device Lot Number: 9326776
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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