MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM 18 G X 1.00 IN.; INTRAVASCULAR CATHETER

Catalog Number	383346
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd saf-t-intima¿ closed iv catheter system 18 g x 1.00 in the stylet separated.The following information was provided by the initial reporter: detailed description: when needle/catheter was inserted into the patient¿s vein and the needle was attempted to be removed, the needle remained in the catheter and in the patient¿s vein but the safety wire was removed.It was observed that the safety wire had been detached from the needle leaving the needle and catheter in the patient¿s vein.Sample saved? yes.Biohazard? yes.
Additional Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 2235998.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.Although a sample was submitted to our facility, current customs law in china prevents the importation of used medical devices.Images of the device were taken at a third-parry location and submitted for review by our quality engineers.Based on the images of the junction surface of the needle, characteristic markings suggest an issue with the crimping process contributed to this event.Crimping malfunctions can be further evaluated through the analysis of the guidewire component, which was not returned with the affected device.Unfortunately without this component our engineers were not able to further narrow down the root cause for this event.
Event or Problem Description
It was reported while using bd saf-t-intima¿ closed iv catheter system 18 g x 1.00 in the stylet separated.The following information was provided by the initial reporter: detailed description: when needle/catheter was inserted into the patient¿s vein and the needle was attempted to be removed, the needle remained in the catheter and in the patient¿s vein but the safety wire was removed.It was observed that the safety wire had been detached from the needle leaving the needle and catheter in the patient¿s vein.Sample saved? yes.Biohazard? yes.

• Brand Name: BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM 18 G X 1.00 IN.
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17439921
• Report Number: 3014704491-2023-00407
• Device Sequence Number: 16821895
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: (01)30382903833468
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: 08/31/2026
• Device Catalogue Number: 383346
• Device Lot Number: 2235998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2022
• 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