MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS; 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 04/06/2023

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 had foriegn matter the following information was provided by the initial reporter; 1.Time of use of medical devices: on (b)(6) 2023; 2.Reasons for using medical devices: indwelling needles; 3.Use of medical devices (whether they are used normally or not): no 4.Time of adverse event occurrence: on (b)(6) 2023; 5.What happens when the medical device is defective: stains are found after unpacking 6.Time for taking measures: on (b)(6) 2023; 7.Result after treatment: replace with a new indwelling needle.

Event Description

No additional information provided.

Manufacturer Narrative

1.Complaint description:foreign matter.2.Dhr/bhr review: (1)the batch number of the complained product is 2312873, is 24g and product code is 383911, produced on 2022/11, 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; 3.The customer did not return any samples or photos, can not confirm the specific situation of the foreign matter; 4.Take the retained samples 29pcs do the inspection, and no abnormalities were found.The inspection report is attached as attachment 1; 5.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, the customer did not return any samples or photos, can not confirm the specific situation of the foreign matter, the root cause of the complaint defect cannot be confirmed, and the factory will continue to pay attention to and monitor the trend of the defect complaint.H3 other text : see narrative.

• Brand Name: BD PEGASUS
• 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: 18177004
• MDR Text Key: 328638612
• Report Number: 3014704491-2023-00747
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903839117
• UDI-Public: (01)00382903839117
• 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: 12/29/2023

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: 2312873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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