MAUDE Adverse Event Report: NULL; Tubes, vials, systems, serum separators, blood collection

Model Number 4558PECN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injection Site Reaction (4562); Swelling/ Edema (4577)

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported that "the newborn was born one month prematurely in our hospital using the blood collection device to detect blood oxygen content.The puncture site was red and swollen, which increased the pain of the child.Symptoms subsided after switching to other products and treating the red and swollen area for 3 days".

• Type of Device: Tubes, vials, systems, serum separators, blood collection
• Manufacturer (Section G): NULL
• MDR Report Key: 13586021
• MDR Text Key: 288996760
• Report Number: 3012307300-2022-03969
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2023
• Device Model Number: 4558PECN
• Device Catalogue Number: 4558PECN
• Device Lot Number: 4076691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention