MAUDE Adverse Event Report: RADIOMETER MEDICAL APS. CLINITUBES; CLINITUBES (CAPILLARY TUBES)

Model Number D957G-70-100

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 05/28/2015

Event Type  Injury  

Manufacturer Narrative

The affected lot will be investigated upon receipt at radiometer medical aps.Also, it is being investigated if the staff member came in to contact with patient blood in relation to the cut.The result of this investigation will be included in the final report.This is a resubmission of the initial mdr, in which mfr report # was incorrectly stated as cfn-based rather than fei-based (3002807-2015-000027 rather than 3002807968-2015-000027).No fields, in addition to mfr report # and have been changed since the original submission.

Event Description

On (b)(6) 2015 a capillary tube (clinitube) snapped while a staff member in a neonatal hospital unit was taking a sample from an infant.While holding the tube to sample, the tube snapped in half piercing the glove, causing a cut and leaving a shard of glass in the wound.The customer reported, that the staff member was trained in the use of the device.

Manufacturer Narrative

The actual clinitube that broke was discarded by the customer.Clinitubes from the same lot were returned to and investigated by radiometer.The investigation of the clinitubes showed no deviation of the affected lot from the expected quality.It has not been possible to establish the root cause of this event.This is a resubmission of the follow-up no 1 mdr, in which mfr report # was incorrectly stated as cfn-based rather than fei-based (3002807-2015-000027 rather than 3002807968-2015-000027).

Event Description

No information of the customer coming into contact has been received.

• Brand Name: CLINITUBES
• Type of Device: CLINITUBES (CAPILLARY TUBES)
• Manufacturer (Section D): RADIOMETER MEDICAL APS.; aakandevej 21; broenshoej; dk-2700 broenshoej 02700
• Manufacturer (Section G): RADIOMMETER MEDICAL APS.; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: kristina toft ; aakandevej 21; broenshoej, 2700 ; DA 2700 ; 538273349
• MDR Report Key: 6441921
• MDR Text Key: 71100621
• Report Number: 3002807968-2015-00027
• Device Sequence Number: 1
• Product Code: GIO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXCEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: D957G-70-100
• Device Catalogue Number: 942-878
• Device Lot Number: LV-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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; Disability