MAUDE Adverse Event Report: BD SUZHOU (MDS) BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383069

Device Problem Break (1069)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that bd intima-ii y 22gax1.00in prn ec slm npvc needle broke.The following information was provided by the initial reporter, translated from chinese to english: the nurse checked that the packaging of the closed iv indwelling needle was intact and unbroken before the operation, and that the indwelling needle was not bent or fractured.However, during the operation, it was found that the retraction of the indwelling needle core broke after the core was withdrawn, which did not cause any harm to the patient.

Manufacturer Narrative

E1.Address information was not provided, therefore,(b)(6) was used as a place holder.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 Description

No additional information provided.

Manufacturer Narrative

1.No defective samples and photos have been received, and based on limited information, it is difficult to determine the defect status of the needle core.Is there a bend in the notch of the needle core? 2.Dhr/bhr review(lot#3234439): 1)this batch of products were assembled at intima ii auto line 3 in september 2023, and packaged at cfs package line in september 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.4)the needle core batch used in this batch of products is 3116452, review the incoming inspection results, no abnormalities.3.The retained sample of this batch is taken, the dimension of the notch of the needle core is measured, and the rigidity and toughness of the needle core are tested.The results are all within the product specifications.Please see attachment for the 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 about this batch of products.As the defect status of the complained sample cannot be confirmed, and the skin and vascular conditions of the patient and the puncture method of the nurse are unknown, the root cause of the defect in the needle core cannot be determined.The plant will continue to follow up on the complaint.

• Brand Name: BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18775110
• MDR Text Key: 337077286
• Report Number: 3002601200-2024-00056
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830695
• UDI-Public: (01)00382903830695
• 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
• Report Date: 04/17/2024

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: 383069
• Device Lot Number: 3234439
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/25/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1