MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS YEL 24GA X0.75IN PRN; INTRAVASCULAR CATHETER

Catalog Number 383715

Device Problem Complete Blockage (1094)

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

Event Date 09/28/2023

Event Type  malfunction  

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.

Event Description

It was reported the bd pegasus yel 24ga x0.75in prn had a clogged / blocked needle the following information was provided by the initial reporter; during the process of draining fluid from an indwelling needle puncture, it is found that the indwelling needle does not drain fluid and the needle tube is clogged, so the indwelling needle is immediately replaced to solve the problem.

Manufacturer Narrative

1.Complaint description: needle clogged /blocked.2.Dhr: the batch number of the complained product is 3079634, is 24g and product code is 383715, produced on 2023/04, with a total of 114000 pieces in this batch inspection process inspection and delivery inspection report, the test results meet the product standards, no abnormality; 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; 3.The customer did not return any samples or photos, cannot confirm the specific defect status; 4.Take the retained sample of this batch for occlusion test and flow test , and no abnormality was found.Test report refer to attachment 1.5.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.H3 other text : see narrative.

Event Description

No additional information provided.

• Brand Name: PEGASUS YEL 24GA X0.75IN PRN
• 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: 17958538
• MDR Text Key: 325962599
• Report Number: 3014704491-2023-00658
• 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,Followup
• Report Date: 12/08/2023

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: 383715
• Device Lot Number: 3079634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1