MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-12-09 for CAPILLARY CAPS 08685906 manufactured by Siemens Healthcare Diagnostics.
[5192654]
Customer reported that capillary caps were very stiff. Customer also reported that they were using these caps in combination with siemens 100 & 140 ul glass capillaries. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[12506299]
This event is under investigation. The cause for the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[34215777]
Additional information: siemens investigation identified that a material change made by the supplier has resulted in capillary caps that are more difficult to apply to the capillaries. An urgent field safety notice #32320 was sent by e-mail to all affected siemens healthcare diagnostics regional offices on january 22, 2015 both in the united states and elsewhere for communication with affected customers. Please note: these capillary caps are an "off the shelf" item. Siemens purchases them from a distributor and repackages them.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2014-00188 |
| MDR Report Key | 4309718 |
| Report Source | 06,07 |
| Date Received | 2014-12-09 |
| Date of Report | 2014-10-20 |
| Date of Event | 2014-10-19 |
| Date Mfgr Received | 2015-01-23 |
| Date Added to Maude | 2014-12-17 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | NORTHERN ROAD CHILTON INDUSTRIAL ESTATE |
| Manufacturer City | SUDBURY MA 02062CO10 |
| Manufacturer Country | UK |
| Manufacturer Postal | 02062CO10 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | VITREX MEDICAL A/S |
| Manufacturer Street | VASEKAER 6-8 2730 HERLEV. |
| Manufacturer Country | DA |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1217157-01-22-2015-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPILLARY CAPS |
| Generic Name | CAPILLARY CAPS |
| Product Code | GIO |
| Date Received | 2014-12-09 |
| Catalog Number | 08685906 |
| Lot Number | 08685906 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-09 |