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

Catalog Number 383912

Device Problem Fitting Problem (2183)

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

Event Date 12/12/2023

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 adapter / connector defective / damaged the following information was provided by the initial reporter: when giving intravenous fluids to a patient, the connection between the indwelling needle and the infusion connector could not be tightened, after replacing it, it was normal, replaced with a new consumable, and it was used normally without causing any harm to the patient.

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 2347346, is 24g and product code is 383912, produced on 2023/01, with a total of (b)(4) pieces in this batch; (2)inspection process and delivery test report, test results meet product standards, no abnormalities; (3)check the production record of the batch of products, no conformance, deviation or rework activities in the process of the batch of products; 2.The customer did not return samples and photos, and the defect status cannot be confirmed.3.Take the retained sample of this batch for 45psi system leakage 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,due to the lack of samples returned by the customer, the specific defect status cannot be confirmed, therefore the root cause of the complaint cannot be confirmed.The factory will continue to monitor the trend of the defect complaint.

• 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: 18553226
• MDR Text Key: 333517126
• Report Number: 3014704491-2024-00019
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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: 383912
• Device Lot Number: 2347346
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1