MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CAPILLARY CAPS

Catalog Number 08685906

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2014

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

This event is under investigation.The cause for the event is unknown.

Manufacturer Narrative

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.

• 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: 4309718
• MDR Text Key: 5192654
• Report Number: 1217157-2014-00188
• Device Sequence Number: 1
• Product Code: GIO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 08685906
• Device Lot Number: 08685906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Removal/Correction Number: 1217157-01-22-2015-001-C
• Patient Sequence Number: 1