MAUDE Adverse Event Report: RADIOMETER MEDICAL APS CLINITUBES; GLASS CAPILLARY TUBES

Model Number D957G-70-125

Device Problem Break (1069)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/19/2014

Event Type  Injury  

Event Description

When the user (technician) was drawing blood from an infant the capillary broke when the end cap was being put on.The users left middle finger was punctured.Gloves were worn.The report states that the user was treated and released from the ed and sent home.No specific information regarding the treatment was given.

Manufacturer Narrative

Test of the breaking force of clinitubes from the reference stock of lot jv-02 has been performed and compared to the breaking force of the previous and following lots produced (jw-01 and jt-01).The breaking force of lot jv-02 was not statistically different from the breaking force of lot jw-01 or jt-01, and no other complaints regarding this lot have been received.Since these clinitubes are made of glass there is a risk that they can break.The hospital has now changed to use safe clinitubes (made of plastic) to avoid this problem in the future.Information about the potential risk of infection from the infant has been requested but not yet received.

Manufacturer Narrative

The following information was found during an internal review at radiometer medical on (b)(6) 2017; information about the potential risk of infection from the patient has been received from the customer, which states that the patient was not in isolation for anything contagious.

• Brand Name: CLINITUBES
• Type of Device: GLASS CAPILLARY TUBES
• Manufacturer (Section D): RADIOMETER MEDICAL APS; bronshoj 2700 ; DA 2700
• Manufacturer Contact: akandevej 21; bronshoj ; 8273827
• MDR Report Key: 3682935
• MDR Text Key: 4260969
• Report Number: 3002807968-2014-00007
• Device Sequence Number: 1
• Product Code: GIO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

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 Expiration Date: 10/01/2015
• Device Model Number: D957G-70-125
• Device Catalogue Number: 942-880
• Device Lot Number: JV02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other