MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II 24GAX0.75IN PRN SLM; INTRAVASCULAR CATHETER

Catalog Number 383028

Device Problems Loose or Intermittent Connection (1371); Dull, Blunt (2407)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

It was reported that bd intima-ii 24gax0.75in prn slm needle was loose.The following information was provided by the initial reporter; on july 4, 2023, the nurse in charge found that the indwelling needle was loose when performing infusion for the patient, making it impossible to perform normal infusion treatment.She immediately replaced the indwelling needle with a new one for infusion.

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.

Manufacturer Narrative

1.According to the chinese description: the indwelling needle is found to stall during infusion, it is determined that the defect of the indwelling needle is: flow rate slow.2.No defective samples and photos have been received for the complaint.1.Dhr/bhr review(lot#3108378): 1) this batch of products were assembled at intima ii auto line 2 in may 2023, and packaged at r240 package line in may 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 defective samples and photos have been received, and based on limited information, it is difficult to determine the defect of the indwelling needle, is the needle dull? is there a pause in the infusion? 3.The retained sample of this batch is taken for relevant testing: lie distance test, penetration force test and flow test, and the test results are all within the product specifications.Please see attachment pr#9150270-1, pr#9150270-2 for test reports.4.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, and no similar complaints have been received from other hospitals regarding this batch of products.As the defect status of the complained sample cannot be determined and the usage of the sample is unknown, the root cause cannot be determined.The plant will continue to follow up on the complaint.H3 other text : see narrative.

Event Description

Lot number provided: 3108378.

Manufacturer Narrative

1.According to the chinese description: the indwelling needle is found to stall during infusion, it is determined that the defect of the indwelling needle is: flow rate slow.2.No defective samples and photos have been received for the complaint.1.Dhr/bhr review(lot#3108378): 1)this batch of products were assembled at intima ii auto line 2 in may 2023, and packaged at r240 package line in may 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.3)review the production records with no nonconformance, deviation or rework activities.2.No defective samples and photos have been received, and based on limited information, it is difficult to determine the defect of the indwelling needle, is the needle dull? is there a pause in the infusion? 3.The retained sample of this batch is taken for relevant testing: lie distance test, penetration force test and flow test, and the test results are all within the product specifications.Please see attachment pr# (b)(4), pr# (b)(4) for test reports.4.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, and no similar complaints have been received from other hospitals regarding this batch of products.As the defect status of the complained sample cannot be determined and the usage of the sample is unknown, the root cause cannot be determined.The plant will continue to follow up on the complaint.H3 other text : see narrative.

Event Description

Additional information provided.After confirming with customer, the sample can not be returned as the product has been discarded.The batch# is 3108378.Attempt, date:2024-3-7, name:(b)(6), method: phone comment(sent): 1.Event description is too vague can you please elaborate on the nature of malfunction? comment(rec): 1.Needle blunt.

• Brand Name: BD INTIMA-II 24GAX0.75IN PRN SLM
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18167406
• MDR Text Key: 328514642
• Report Number: 3014704491-2023-00745
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2024

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: 3108378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/19/2023
• Supplement Dates Manufacturer Received: 03/12/2024; 03/12/2024
• Supplement Dates FDA Received: 03/19/2024; 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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