MAUDE Adverse Event Report: BD SUZHOU (MDS) BD INTIMA-II Y 26GAX0.56IN MZPRN SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383287

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

It was reported that bd intima-ii y 26gax0.56in mzprn slm npvc had foreign matter the following information was provided by the initial reporter: 2024.03.25 at 9 o'clock, the patient was given infusion treatment in accordance with the doctor's orders, because the patient's vascular elasticity is poor, it is necessary to use a closed intravenous needle for infusion treatment, open the sterile package and found that there is a foreign body in the needle, immediately stop using the needle to replace the other needle after the treatment was successfully completed.

Manufacturer Narrative

If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

1.Dhr/bhr review(lot#3164594): 1) this batch of products were assembled at intima ii manual line in july 2023, and packaged at r245 package line in july 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 for the complaint.3.Check the retained samples of this batch, no foreign matters are found.Please see attachment for the inspection report.4.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormalities are found in the process and retained samples, and no similar complaints have been received from other hospitals about this batch of products.As the status and composition of the foreign matter in the unit package cannot be confirmed, the root cause of this defect cannot be determined.The plant will continue to pay attention to and monitor such defects.

Event Description

Fm did not compromise the packaging seal and was not in the fluid pathway.No additional information provided.

• Brand Name: BD INTIMA-II Y 26GAX0.56IN MZPRN 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 (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19163827
• MDR Text Key: 341666103
• Report Number: 3002601200-2024-00145
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• 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
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383287
• Device Lot Number: 3164594
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1