MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS Y 24GA X 0.75IN SS PRN NPVC; INTRAVASCULAR CATHETER

Catalog Number 383904

Device Problem Improper Flow or Infusion (2954)

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

Event Date 11/23/2023

Event Type  malfunction  

Event Description

It was reported that bd pegasus y 24ga x 0.75in ss prn npvc is difficult to infuse.The following information was provided by the initial reporter, translated from chinese to english: in the process of using the indwelling needle on november 23, it was found that after sealing the tube, the patient's small activities can cause the blood in the tube to flow back, which is easy to cause tube blockage; after the indwelling needle tube snap is opened, the tube is difficult to rebound, and the infusion of fluids at the snap folding place is not smooth.

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.Dhr/bhr review: (1) the batch number of the complained product is 3247503, is 24g and product code is 383904, produced on 2023/09, 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 any samples or photos, cannot confirm the specific defect status; 3.Take the retained sample of this batch for occlusion test, flow test and extension tube clamping test and no abnormality was found.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, due to the customer did not return any samples or photos, the specific status of the occlusion cannot be confirmed.Therefore, the root cause of the complaint cannot be confirmed.The factory will continue to monitor the trend of the defect complaint.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS Y 24GA X 0.75IN SS PRN 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: 18645043
• MDR Text Key: 335741174
• Report Number: 3002601200-2024-00012
• 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: 03/18/2024

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: 3247503
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1