MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS Y 24GA X 0.75IN SS PRN NPVC; 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 10/24/2023

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 that bd pegasus y 24ga x 0.75in ss prn npvc had rust / corrosion the following information was provided by the initial reporter; while in use, corrosion was found on the indwelling needle, and four unopened indwelling needles were also found to be corroded.Immediately reported to the equipment section.

Manufacturer Narrative

1.Dhr/bhr review: (1) the batch number of the complained product is 3136595, is 24g and product code is 383904, assembled on the automatic line in 2023/06, and packaged on the cfs packaging machine in 2023/06, with a total of (b)(4) pieces in this batch; (2) check the process inspection and delivery inspection report.The test results all meet the product standards and there are no abnormalities; (3) check the production records, there were no nonconformance, deviation or rework activities.2.No samples or pictures were returned,the defect status cannot be confirmed; 3.Take the retained sample of this batch for corrosion resistance 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, there were no abnormalities found in the process and retained samples, and the customer did not return any samples or photos.Can not confirm whether the corroded parts are needles or v-clip, and no similar complaints have been received from other hospitals regarding this batch of products.Under normal circumstances, the indwelling needle has good corrosion resistance, but in special circumstances, such as containing chlorine (or sodium hypochlorite) and other corrosive gases, some needles may rust.The plant does not have the conditions to cause such defect in the production process, which may be related to the transportation and storage of the indwelling needle in the later stage.The factory will continue to monitor and monitor the trend of defect complaints.

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); 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: 18220582
• MDR Text Key: 329158456
• Report Number: 3014704491-2023-00762
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903839049
• UDI-Public: (01)00382903839049
• 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: 01/29/2024

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: 3136595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1