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

Catalog Number 383710

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

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

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported that there was foreign matter observed on 10 bd pegasus 24ga x 0.75in ss npvc.The following information was provided by the initial reporter, translated from chinese to english: emergency pediatric customers reported that when using our huima and they found that there were black spots, yellow and other foreign bodies at the joint of smersel.

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.An additional lot number was provided in this complaint for material number 383710.Lot # 3170884 mnf date 06/19/2023 exp date 07/18/2026.

Manufacturer Narrative

1.Dhr/bhr review: (1)this complaint involves two batches of products, one batch number is 3247505, is 24g, and product code is 383710,produced on 2023/09, with a total of 38000 pieces in this batch; the other batch of products batch number is 3170884, is 24g, and product code is 383710; produced on 2023/07,with a total of 19000 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 samples and only provided 2 photos of defective products.From photo 1, it can be seen that there are black dots on the smart-site, suspected to be embedded in the connector; from photo 2, it can be seen that there is a yellow foreign matter on the smart-site, and it cannot be confirmed whether the foreign matter is embedded in the connector or movable.3.Take the retained 30pcs samples of batch 3247505,and 30pcs samples of batch 3170884, do the inspection, and no abnormalities were found.The inspection report is attached as 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, based on the photos provided by the customer, it is suspected that the black dot foreign matter is embedded in the connector.Smartsite is manufactured by bd¿s internal supplier, already fed back to the supplier for investigation and improvement.Attached related email.The yellow foreign matter cannot be confirmed whether it is embedded in the connector, or movable foreign matter,and the component of the foreign matter can not be confirmed.Therefore, the root cause of the yellow foreign matter cannot be confirmed.For the 383710 products, have trained the operator do 100% visual inspection before packaging.The factory will continue to monitor and monitor the trend of defect complaints.H3 other text : see narrative.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS 24GA X 0.75IN SS 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: 18660680
• MDR Text Key: 334783021
• Report Number: 3002601200-2024-00021
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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: Health Professional
• Device Catalogue Number: 383710
• Device Lot Number: 3247505
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1