MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-03 for SAFECLINITUBES 905-787 manufactured by Radiometer Medical Aps.
[2562308]
The capillary end caps came off the tube during transport, causing the blood sample to be wasted. The user had to stick the pt again in order to resample.
Patient Sequence No: 1, Text Type: D, B5
[9698163]
The typical failure modes for the end caps is either leakage because the end caps fall of during transport in pneumatic tubes (loose fit) or breaking of glass capillary tubes when mounting the end caps (tight fit). The end caps inner diameter were narrowed from lot 1037508 after a thorough review of the product through post marketing surveillance. After this customer's initial complaint in (b)(6) 2011 their stock was replaced by a newer lot of end caps. There have been no further complaints from this customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2011-00020 |
| MDR Report Key | 2427385 |
| Report Source | 05,06 |
| Date Received | 2012-01-03 |
| Date of Report | 2011-12-05 |
| Date of Event | 2011-10-21 |
| Date Mfgr Received | 2011-12-05 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2012-07-27 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LASSE MOLLER, SPECIALIST |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273436 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFECLINITUBES |
| Generic Name | CAPPILLARY CAP |
| Product Code | GIO |
| Date Received | 2012-01-03 |
| Catalog Number | 905-787 |
| Lot Number | 1034521 |
| 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 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-03 |