MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383756

Device Problem Leak/Splash (1354)

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

Event Date 03/20/2024

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 gn 18gax1.16in prn-cap y non-pvc leaked the following information was provided by the initial reporter: on (b)(6) 2024, the patient was undergoing preoperative rehydration therapy for endometrial cancer as prescribed by the physician, and a closed anti-needle-stick injury type iv indwelling needle was given at 10:12 to open venous access, and there was a leakage at the end of the indwelling needle at 10:14, which was immediately reassured to the patient and replaced with a new one of the same type for use.

• Brand Name: BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC
• 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): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19198339
• MDR Text Key: 341276740
• Report Number: 3002601200-2024-00155
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903837564
• UDI-Public: (01)00382903837564
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2024

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: 383756
• Device Lot Number: 3234106
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1