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

Catalog Number 383069

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd intima-ii y 22gax1.00in prn ec slm npvc heparin cap detached.The following information was provided by the initial reporter, translated from chinese to english: the patient was diagnosed with an intertrochanteric fracture of the femur.On (b)(6) 2024, he underwent internal fixation surgery for an intertrochanteric fracture of the femur and needed to replenish body fluids.Following the doctor's instructions, he placed an intravenous catheter in the patient's body and then added intravenous fluids.When he was about to open the indwelling needle, he found that the heparin cap of the indwelling needle had fallen off.

Manufacturer Narrative

1.Dhr/bhr review (lot#3325896): 1) this batch of products were assembled at intima ii auto line 3 in november 2023, and packaged at r240 package line and cfs package line in november 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.2.No defective samples and photos have been received for the complaint.3.The retained sample of this batch is taken for prn torque test, and the test result is within the product specifications.Please see the attachment for the test report.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 will alarm and remove the product.However, although prn is fastened to the product during assembly, it may come loose if it is vibrated during transportation.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, and no similar complaints have been received from other hospitals regarding this batch of products.As no defective samples are received for further analysis and confirmation, the root cause of prn falling off cannot be determined, and the plant will continue to track and monitor the defect.

Event Description

No additional information provided.

• 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: 18895940
• MDR Text Key: 337775999
• Report Number: 3002601200-2024-00079
• 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: 03/25/2024

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: 3325896
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1