MAUDE Adverse Event Report: BD (SUZHOU) BD UNKNOWN; INTRAVASCULAR CATHETER

Catalog Number 383904

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

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

Event Date 10/08/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that unknown bd had foreign matter.The following information was provided by the initial reporter: hepatobiliary surgery nurse checked the outer package was intact while administering fluids to a patient.Opened the package for use and found a small number of red dots in the lumen of the connecting indwelling needle tube, immediately replaced it with a new one for use and reported it to the nurse manager and medical equipment department teacher.

Event Description

No additional information provided: lot number associated with material# 383904.

Manufacturer Narrative

1.Dhr/bhr review: (1) the batch number of the complained product is 3079628, is 24g and product code is 383904, produced on 2023/04, with a total of (b)(4) pieces in this batch; (2) inspection process inspection and delivery inspection report, the test results meet the product standards, no abnormality; (3) check the production records for this batch of products that there are no nonconformities, deviations or rework activities in the process of this batch of products; 2.The customer did not return samples or photos, can not confirm whether the red dot foreign matter appeared before or after use, and the component of the foreign matter can not be confirmed; 3.Take the retained samples 30pcs do the inspection, and no abnormalities were found.The inspection report is attached as attachment 1; 4.The history of customer complaints for the same batch of products has been reviewed, and no complaints of the same defects have been found.In summary, the customer did not return any samples or photos, can not confirm whether the red dot foreign matter appeared before or after use, and the component of the foreign matter can not be confirmed, the root cause of the complaint defect cannot be confirmed,the factory will continue to pay attention to and monitor the trend of the defect complaint.

• Brand Name: BD UNKNOWN
• 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: 18431412
• MDR Text Key: 331885715
• Report Number: 3014704491-2023-00864
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 03/04/2024

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: 383904
• Device Lot Number: 3079628
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1