MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-03-29 for CLINITUBES D957G-70-100 942-878 manufactured by Radiometer Medical Aps..
[71100621]
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.
Patient Sequence No: 1, Text Type: N, H10
[71100622]
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.
Patient Sequence No: 1, Text Type: D, B5
[71869669]
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).
Patient Sequence No: 1, Text Type: N, H10
[71869670]
No information of the customer coming into contact has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2015-00027 |
| MDR Report Key | 6441921 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-29 |
| Date of Report | 2016-02-02 |
| Date of Event | 2015-05-28 |
| Date Mfgr Received | 2016-02-02 |
| Date Added to Maude | 2017-03-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KRISTINA TOFT |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | 538273349 |
| Manufacturer G1 | RADIOMMETER MEDICAL APS. |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITUBES |
| Generic Name | CLINITUBES (CAPILLARY TUBES) |
| Product Code | GIO |
| Date Received | 2017-03-29 |
| Returned To Mfg | 2015-11-12 |
| Model Number | D957G-70-100 |
| Catalog Number | 942-878 |
| Lot Number | LV-01 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS. |
| Manufacturer Address | AAKANDEVEJ 21 BROENSHOEJ DK-2700 BROENSHOEJ 02700 US 02700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2017-03-29 |