MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CAPILLARY CAPS

Catalog Number 10311054

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem Injury (2348)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

(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.

• Brand Name: CAPILLARY CAPS
• Type of Device: CAPILLARY CAPS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): VITREX MEDICAL A/S; vasekaer 6-8; 2730 herlev.; DA
• Manufacturer Contact: steven andberg ; northern road; chilton industrial estate; sudbury, MA 02062-CO10 ; UK 02062CO10 ; 7812693655
• MDR Report Key: 4274206
• MDR Text Key: 5030884
• Report Number: 1217157-2014-00178
• Device Sequence Number: 1
• Product Code: GIO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10311054
• Device Lot Number: 1710264N
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: 1217157-01-22-2015-001-C
• Patient Sequence Number: 1