MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS BL 22GA X 1.00IN PRN NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383735

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported that bd pegasus bl 22ga x 1.00in prn non-pvc tubing was defective/damaged.The following information was provided by the initial reporter; the patient was performing a ct enhancement examination at 15:55 p.M.On (b)(6), when the high-pressure syringe suddenly stopped injecting, and later examination revealed swelling at the indwelling needle extension tube, interrupting the examination, which was explained to the patient and another appointment was made for the examination.

Manufacturer Narrative

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

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 3013900, is 22g and product code is 383735, produced on (b)(6) 2023, with a total of 38000 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 any samples or photos, can not confirm the specific defect status of the product; 3.Take the retained sample of this batch for 300psi burst 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, no abnormalities were found during high-pressure burst testing of the retained sample.As the actual type of liquid used by the customer and injection pressure cannot be determined, the root cause of the complaint cannot be confirmed.The factory will continue to monitor and monitor the trend of this defect complaint.H3 other text : see narrative.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS BL 22GA X 1.00IN PRN NON-PVC
• 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: 18345436
• MDR Text Key: 331084144
• Report Number: 3014704491-2023-00828
• 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
• Report Date: 03/14/2024

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: 383735
• Device Lot Number: 3013900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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