MAUDE Adverse Event Report: RADIOMETER MEDICAL APS CLINITUBES

Model Number 942-880

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

Incident date is estimated.

Event Description

According to the complaint, a nurse cut herself with a broken clinitube.The clinitube had been used to collect blood from a baby and the hospital has confirmed that the baby doesn't have any infectious pathology.

Manufacturer Narrative

The broken clinitube was not available for investigation and no photo or lot number was provided.Based on the provided information, root cause of this accident is the material of clinitube- glass.Glass is a very fragile material, so the end user should be very careful when using these clinitubes.Due to the possibility of cutting the skin by the glass material of clinitubes, it is recommended to use safeclinitubs, which are made of plastic, which is much less brittle and more resistant to cracking during use.

• Brand Name: CLINITUBES
• Type of Device: CLINITUBES
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 15128121
• MDR Text Key: 296846920
• Report Number: 3002807968-2022-00026
• Device Sequence Number: 1
• Product Code: GIO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 942-880
• Device Catalogue Number: 942-880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other