MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-02-21 for CLINITUBES D957G-70-125 942-880 manufactured by Radiometer Medical Aps.
[4260969]
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.
Patient Sequence No: 1, Text Type: D, B5
[11549299]
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.
Patient Sequence No: 1, Text Type: N, H10
[74378110]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2014-00007 |
| MDR Report Key | 3682935 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-02-21 |
| Date of Report | 2017-05-02 |
| Date of Event | 2014-01-19 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Manufacturer Phone | 8273827 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITUBES |
| Generic Name | GLASS CAPILLARY TUBES |
| Product Code | GIO |
| Date Received | 2014-02-21 |
| Model Number | D957G-70-125 |
| Catalog Number | 942-880 |
| Lot Number | JV02 |
| Device Expiration Date | 2015-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | BRONSHOJ 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-21 |