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

Catalog Number 383912

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

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

Event Date 03/26/2024

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 bd pegasus yel 24ga x 0.75in prn-cap y had rust the following information was provided by the initial reporter: nurse manager reported that the metal inside the safety device was found to be rusty before the product was used, number of units affected 3, samples can be returned 2, photos available, complaint response letter required, complaint receipt letter required, green claim required.

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 3310008, is 24g and product code is 383912, produced on 2023/11, 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 returned 2pcs samples, 1pcs had been opened and used, with traces of liquid medicine on the single packaging paper, and 1pcs had not been opened and was not used,opened the packaging paper, found that the surface color of the packaging paper was a little yellow, as shown in the photos 1-3; taken out the product, and found that the v-clip, washer and needle are all rusted, as shown in the photos 4-7; 3.The history of customer complaints for the same batch of products has been reviewed, and no complaints of the same defects have been found.Cause analysis: (1) compared the single packaging paper of the customer's returned sample and the retained sample, it was found that the surface of the returned sample packaging paper, except for the surrounding sealed edges, the color is more yellow in the middle than the retained sample,is the result of moisture entering, as shown in the attached photos 8-9; (2) compared the prn of the sample returned by the customer and the retained sample, it was found that the prn's color of the returned sample were darker than the retained sample, suspected of oxidation, as shown in the photos 10-11; (3) in the returned sample, the washer and needle, which are inside the product and not easily exposed to the external environment, are also rusted; (4) no rust was found on the retained sample products, as shown in the attached photo 12.In summary, no rust was found in the sample products, and no similar complaints were received from other hospitals about this batch of products.According to the analysis of the samples returned by the customer, it is confirmed that the rust of the product is due to the product being placed in a humid environment.The moisture enters the inside of the package through the packaging paper, causing the metal parts of the product to 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 products in the later stage.The factory will continue to monitor and monitor the trend of defect complaints.H3 other text : see narrative.

• 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 (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19198285
• MDR Text Key: 341271285
• Report Number: 3002601200-2024-00154
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383912
• Device Lot Number: 3310008
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1