MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER; INTRAVASCULAR CATHETER

Model Number	383346
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 y adapter experienced leakage at the catheter and hub junction.The following information was provided by the initial reporter: we used the device as a return line catheter to a patient during a peripheral access apheresis procedure.The flow rate was about 30ml/min (which includes the ¿return¿ blood flow from the apheresis machine plus a calcium gluconate infusion, which was connected to the additional port on the catheter).The issue was discovered when the patient raised his arm to show that there was blood running down his arm and the dressing to secure the iv site was saturated.The apheresis collection procedure was paused and the site was undressed and cleaned to assess where the blood was coming from.The catheter itself was in place and was not leaking from the venipuncture site but was noted trickling where the catheter connects to the wings.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for evalution? yes.D.9.Returned to manufacturer on: 04-oct-2022 h.6.Investigation summary: in response to the event reported a device history review was conducted for lot number 1041999.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample was submitted to aid in our investigation , unfortunately due to the current customs law in china, used medical devices cannot be imported to the facility of manufacture.To mitigate the affect this has on our investigation, high resolution magnified photographs were taken of the device and submitted to our engineers for review.Our engineers were not able to identify any characteristic damage or deformities on the surface of the device that would contributed to the reported leakage.Additionally, functional testing was performed on the retention samples for the affected lot.Test results indicate that the retained devices were free of any nonconformance and operated within product parameters.Unfortunately without the ability to observe or replicate the reported non-conformance our quality engineers were unable to determine the root cause for this complaint.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.
Event or Problem Description
It was reported that the bd saf-t-intima¿ safety system with y adapter experienced leakage at the catheter and hub junction.The following information was provided by the initial reporter: we used the device as a return line catheter to a patient during a peripheral access apheresis procedure.The flow rate was about 30ml/min (which includes the ¿return¿ blood flow from the apheresis machine plus a calcium gluconate infusion, which was connected to the additional port on the catheter).The issue was discovered when the patient raised his arm to show that there was blood running down his arm and the dressing to secure the iv site was saturated.The apheresis collection procedure was paused and the site was undressed and cleaned to assess where the blood was coming from.The catheter itself was in place and was not leaking from the venipuncture site but was noted trickling where the catheter connects to the wings.

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15620747
• Report Number: 3014704491-2022-00489
• Device Sequence Number: 5978951
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K923702
• 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): 11/28/2022

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: 02/28/2025
• Device Model Number: 383346
• Device Catalogue Number: 383346
• Device Lot Number: 1041999
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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