MAUDE Adverse Event Report: TIANJIN HUAHONG TECHNOLOGY CO. LTD. CARETOUCH; INSULIN SYRINGE

Model Number CTIS315

Device Problem Product Quality Problem (1506)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Event Description

Customer complaint - limited data available.Customer stated that the syringe needles had burrs which caused tearing of their skin.This was the case with more than half of the box of syringes.

Event Description

Customer complaint - limited data available hello, the issue i experienced was that the needles had burrs on them.Like a jagged piece of metal that didn't get sanded down or whatever.More than half of the needles in the box were like this and i usually became aware of it painfully while inserting the needle into my skin.It would scrape and catch my flesh when being inserted and removed.It makes me cringe thinking about the feeling.I don't know if this is a manufacturing problem or if i got a very unlucky box of syringes.

• Brand Name: CARETOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): TIANJIN HUAHONG TECHNOLOGY CO. LTD.; a01, plant b, no.278, hangkong; tianjin pilot free trade zone(; tianjin 30030 8; CH 300308
• MDR Report Key: 17034126
• MDR Text Key: 316284301
• Report Number: 3016774562-2023-00145
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CTIS315
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2023
• Distributor Facility Aware Date: 09/21/2022
• Date Report to Manufacturer: 10/31/2022
• Patient Sequence Number: 1
• Patient Sex: Female