MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS; INTRAVASCULAR CATHETER

Catalog Number 383732

Device Problem Material Deformation (2976)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

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 tubing was defective/damaged on (b)(6) 2024, in the first ward of the obstetrics department, the nurse gave the patient an indwelling closed needle-proof anti-needle puncture type intravenous indwelling needle under aseptic operation, the puncture was smooth, the blood return was smooth, and the blockage was found to be not drip during the infusion of drugs, the inspection pipeline was not closed, and the transparent compress of the indwelling needle was uncovered and found that the hose under the y-shaped interface was flattened, resulting in the blockage liquid being unable to enter.Immediately reshape the indwelling needle and the infusion is unobstructed.No harm was caused to the patient.

• Brand Name: BD PEGASUS
• 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; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18888728
• MDR Text Key: 337776411
• Report Number: 3002601200-2024-00078
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383732
• Device Lot Number: 3143884
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• 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