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

Catalog Number 383028

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system prn was loose during the infusion and could not be tightened.The following information was provided by the initial reporter, translated from chinese: "usage situation: when the patient is undergoing intravenous infusion, the heparin cap of the indwelling needle is loose and cannot be tightened.The patient is not satisfied with the puncture again due to extravasation of the drug solution.Adverse events: the heparin cap of the indwelling needle is loose and cannot be tightened impact on the victim: the patient was dissatisfied with the puncture again due to extravasation of the medicine.Time to take treatment measures: (b)(6) 2023.Treatment measures taken: replace the indwelling needle.Time for improvement of adverse events: (b)(6) 2023.

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

No new information.

Manufacturer Narrative

1.Dhr/bhr review(lot#3052816): 1)this batch of products were assembled at intima ii auto line 2 in march 2023, and packaged at r240 package line and cfs package line in march 2023.Work order quantity was (b)(4) ea.2)review the in-process test reports and outgoing test reports, and all test results meet the product specifications.Among them, the prn torques meet the outgoing inspection requirement.3)review the production records with no nonconformance, deviation or rework activities.4)the prn batch used in this batch of products is 3045876, review the raw material inspection records, no abnormalities.2.No actual samples and pictures have been received, and the defect status cannot be confirmed.3.The retained sample of this batch is taken for leakage test and prn removal torque test, the leakage test is qualified, there is no leakage at the prn, and the prn removal torque is within the product specifications.(please see attachment for the test reports) 4.In the assembly process of prn, there are torque and assembly stroke monitoring to ensure that the luer of prn can be assembled into the pp connector to a certain depth and the thread has a good fastening effect.If the prn is not in place, the equipment alarms and removes the product.However, although prn is fastened to the product during assembly, prn may come loose if it is vibrated during transportation.Therefore, the ifu of the product indicates that the prn should be tightened before use to prevent leakage.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, the luer status of the prn and the pp connector cannot be confirmed, and the nurse's usage is unknown, and the root cause of the complaint defects cannot be determined.The plant will continue to monitor such defects.H3 other text : see narrative.

Manufacturer Narrative

1.Dhr/bhr review(lot#3052816): 1)this batch of products were assembled at intima ii auto line 2 in march 2023, and packaged at r240 package line and cfs package line in march 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.Among them, the prn torques meet the outgoing inspection requirement.3)review the production records with no nonconformance, deviation or rework activities.4)the prn batch used in this batch of products is 3045876, review the raw material inspection records, no abnormalities.2.No actual samples and pictures have been received, and the defect status cannot be confirmed.3.The retained sample of this batch is taken for leakage test and prn removal torque test, the leakage test is qualified, there is no leakage at the prn, and the prn removal torque is within the product specifications.(please see attachment for the test reports) 4.In the assembly process of prn, there are torque and assembly stroke monitoring to ensure that the luer of prn can be assembled into the pp connector to a certain depth and the thread has a good fastening effect.If the prn is not in place, the equipment alarms and removes the product.However, although prn is fastened to the product during assembly, prn may come loose if it is vibrated during transportation.Therefore, the ifu of the product indicates that the prn should be tightened before use to prevent leakage.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, the luer status of the prn and the pp connector cannot be confirmed, and the nurse's usage is unknown, and the root cause of the complaint defects cannot be determined.The plant will continue to monitor such defects.H3 other text : see h10.

Event Description

Usage situation: when the patient is undergoing intravenous infusion, the heparin cap of the indwelling needle is loose and cannot be tightened.The patient is not satisfied with the puncture again due to extravasation of the drug solution.Adverse events: the heparin cap of the indwelling needle is loose and cannot be tightened.Impact on the victim: the patient was dissatisfied with the puncture again due to extravasation of the medicine.Time to take treatment measures: 2023-09-26; treatment measures taken: replace the indwelling needle; time for improvement of adverse events: 2023-09-26.

• 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: 17946863
• MDR Text Key: 326238750
• Report Number: 3014704491-2023-00653
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830282
• UDI-Public: (01)00382903830282
• 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,Followup
• Report Date: 11/16/2023

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: Other
• Device Catalogue Number: 383028
• Device Lot Number: 3052816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 11/07/2023; 11/16/2023
• Supplement Dates FDA Received: 11/08/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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