MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-11-24 for CAPILLARY CAPS 10311054 manufactured by Siemens Healthcare Diagnostics.
[5030884]
Customer reported that capillary caps were not fitting well to glass capillaries and causing glass capillaries to break. Customer also reported that operator had minor cut on the finger due to this incident. There was no report of medical intervention due to this incident.
Patient Sequence No: 1, Text Type: D, B5
[12569893]
Customer indicated that they do not have any capillaries left from a lot that had not been breaking for investigation. This issue is under investigation. The cause for the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[34037869]
(b)(4). 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 #(b)(4) 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 | 1217157-2014-00178 |
| MDR Report Key | 4274206 |
| Report Source | 06,07 |
| Date Received | 2014-11-24 |
| Date of Report | 2014-10-29 |
| Date of Event | 2014-10-17 |
| Date Mfgr Received | 2015-01-23 |
| Date Added to Maude | 2014-12-03 |
| 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 | 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 | 2014-11-24 |
| Catalog Number | 10311054 |
| Lot Number | 1710264N |
| 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 | 2014-11-24 |