MAUDE Adverse Event Report: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 18 GA 1.00 IN; INTRAVASCULAR CATHETER

Model Number	383346
Medical Device Problem Codes	Leak/Splash (1354); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
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 when using the bd saf-t-intima¿ safety system with y adapter 18 ga 1.00 in there was a safety mechanism failure and tubing clamp loose.This event occurred 2 times.The following information was provided by the initial reporter and translated to english.The customer stated: "during use, it was found the indwelling needle was stuck in the heparin cap due to the jamming of the safety needle withdrawing the needle.".
Event or Problem Description
It was reported when using the bd saf-t-intima¿ safety system with y adapter 18 ga 1.00 in there was a safety mechanism failure and tubing clamp loose.This event occurred 2 times.The following information was provided by the initial reporter and translated to english.The customer stated: "during use, it was found the indwelling needle was stuck in the heparin cap due to the jamming of the safety needle withdrawing the needle.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/1/2021.H.6.Investigation: bd received 2 samples submitted for evaluation.The reported issue was not confirmed upon inspection of the sample.During inspection no samples had damage that could result in the reported failure.Since the reported failure was not confirmed a root cause related to our manufacturing process cannot be established.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 18 GA 1.00 IN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12465114
• Report Number: 9610847-2021-00437
• Device Sequence Number: 19761462
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• 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): 09/27/2021

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: 03/31/2024
• Device Model Number: 383346
• Device Catalogue Number: 383346
• Device Lot Number: 0087326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• 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