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

Catalog Number 383911

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

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

It was reported that bd pegasus yel 24ga x 0.75in prn-cap y had foreign matter the following information was provided by the initial reporter; on (b)(6) 2023, when preparing to insert the indwelling needle, i opened the indwelling needle and found that there was a small black spot on the inner wall of the indwelling needle.It was not used and the indwelling needle was replaced.This incident delayed patient treatment and created a risk of infection.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

Second report pending h3 other text : see narrative.

Event Description

Material number a lot number was provided by the customer.

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 3136597, is 24g and product code is 383911, produced on 2023/06, packaged on the r245 packaging line, 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 a defective sample, as shown in attached photos 1 and 2; under the microscope, it's found that there have black foreign matter inside the catheter adaptor, as shown in attached photo 3; cut and open the catheter adaptor,and it is found that foreign matter was embedded inside the catheter adaptor and cannot be moved, as shown in the attached photo 4; 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) foreign objects cannot be moved and are embedded in the hose seat, confirming that the foreign object comes from the injection molding process of the catheter adaptor; 2) the foreign matter attached to the surface of the injection mold construction may enter the injection molding machine, causing the foreign matter to enter the catheter adaptor.Corrective and preventive measures: 1) training molding operators, strengthen daily cleaning molds, and promptly clean any foreign matters found.Please refer to the attached training records; 2) training assembly line and packaging line operators.If found such defects, need to be promptly removed.Please refer to the attached training record.In summary, after analyzed the returned samples, found that foreign matters were embedded inside the catheter adaptor and could not be moved.It was generated during the molding process, and it may be the foreign matter attached to the surface of the mold construction that entered the molding machine; we have trained molding, assembly line and packaging line operators to promptly remove such defects.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 YEL 24GA X 0.75IN PRN-CAP Y
• 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: 18340647
• MDR Text Key: 330863936
• Report Number: 3014704491-2023-00825
• 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,Followup
• Report Date: 02/28/2024

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: 383911
• Device Lot Number: 3136597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 02/11/2024; 02/11/2024
• Supplement Dates FDA Received: 03/01/2024; 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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