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

Catalog Number 383912

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/11/2024

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 that bd pegasus yel 24ga x 0.75in prn-cap y catheter was difficult to disengage the needle.The following information was provided by the initial reporter, translated from chinese to english: a patient requires an intravenous infusion of albumin and the nurse is required to establish intravenous access to the patient using an indwelling needle.When the indwelling needle is punctured into the vessel and the needle holder handle needs to be withdrawn, there is a snag and difficulty in withdrawing it; the nurse continues to hold the catheter holder in place with her left hand, and with her right hand, she withdraws the entire needle holder handle from the end of the needle holder handle rather than from the handle.The nurse of the entire unit was notified that this problem may be encountered during the puncture of this indwelling needle.The incident did not result in substantial harm.

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 3261315, is 24g and product code is 383912,produced on 2023/10, with a total of 114000 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,the defect status cannot be confirmed.3.Take the retained sample of this batch for system drag force test, and no abnormality was found.Test report refer to 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, due to the lack of samples returned by the customer, the specific defect status 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: BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y
• 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: 18637088
• MDR Text Key: 334956835
• Report Number: 3002601200-2024-00011
• 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: 03/15/2024

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: 383912
• Device Lot Number: 3261315
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/03/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1