MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS BL 22GA X 1.00IN QSYTE-CAP Y; INTRAVASCULAR CATHETER

Catalog Number 383734

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

This event is the same as (b)(4).

Event Description

The patient was treated in the emergency room of our hospital for burns.The nurse performed the venous indwelling puncture and opened a new closed anti-needle puncture type venous indwelling needle, and the needle insertion process was smooth according to the operating specifications.After removing the inner steel needle, there is an abnormality, and blood flows out of the tail end to contact air (the steel needle inside the conjoined body is intact and undamaged).The nurse immediately removed the indwelling hose, disinfected and pressed the local skin, explained to the patient, and took the indwelling needle again to puncture and place the catheter again, and everything went smoothly this time.On february 27, the salesman of the manufacturer brought back the problem indwelling needle and returned to the factory for testing.Google translation.

Event Description

It was reported that bd pegasus bl 22ga x 1.00in qsyte-cap y leaked the following information was provided by the initial reporter: the patient was treated in the emergency room of our hospital for burns.The nurse performed the venous indwelling puncture and opened a new closed anti-needle puncture type venous indwelling needle, and the needle insertion process was smooth according to the operating specifications.After removing the inner steel needle, there is an abnormality, and blood flows out of the tail end to contact air (the steel needle inside the conjoined body is intact and undamaged).The nurse immediately removed the indwelling hose, disinfected and pressed the local skin, explained to the patient, and took the indwelling needle again to puncture and place the catheter again, and everything went smoothly this time.On february 27, the salesman of the manufacturer brought back the problem indwelling needle and returned to the factory for testing.Google translation.

Manufacturer Narrative

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

• Brand Name: BD PEGASUS BL 22GA X 1.00IN QSYTE-CAP Y
• 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): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; suzhou industrial park; singapore 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19176736
• MDR Text Key: 341688479
• Report Number: 3002601200-2024-00151
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 383734
• Device Lot Number: 3143886
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1