MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383083

Device Problems Loose or Intermittent Connection (1371); Defective Component (2292); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system tubing clamp was loose after the infusion was completed, causing blood to return to the heparin cap.The following information was provided by the initial reporter, translated from chinese: "on 8-16, after the 16-bed patient's infusion was completed, the nurse performed a tube closure, and blood returned to the heparin cap of the indwelling needle infusion despite the clamping of the indwelling needle's open and closed clip.".

Manufacturer Narrative

1.Dhr/bhr review(lot#3080061): 1)this batch of products were assembled at intima ii auto line 4 in april 2023, and packaged at r240 package line in april 2023.Work order quantity was 198,000 ea.2)review the in-process test reports and outgoing test reports, and all test results meet the product specifications.3)review the production records with no nonconformance, deviation or rework activities.2.No actual sample and picture have been received , the defect states cannot be confirmed.3.The retained sample of the complaint batch is taken for the pinch clamp sealing test, and the test result is qualified.Please see attachment (b)(4) for the test report.4.Possible causes: 1)failure of the pinch clamp causes blood return.However, in previous tests, it was found that when the extension tubing was not centered in the pinch clamp, the pinch clamp could not be fully acted.Please see (b)(4) for the clamping position view.2)patient factors (such as changes in body position, cough, coagulation disorders, etc.), improper flushing and sealing of tubes lead to blood return.5.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained sample.No similar complaints have been received from other hospitals regarding this batch of products.As no defective sample returned, and the usage is unknown, the root cause of the complaint defects cannot be determined.H3 other text : see h.10.

Event Description

On 8-16, after the 16-bed patient's infusion was completed, the nurse performed a tube closure, and blood returned to the heparin cap of the indwelling needle infusion despite the clamping of the indwelling needle's open and closed clip.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: 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: 17927972
• MDR Text Key: 326263920
• Report Number: 3014704491-2023-00649
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830831
• UDI-Public: (01)00382903830831
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 383083
• Device Lot Number: 3080061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1