MAUDE Adverse Event Report: TECAN SYSTEMS INC BD FACS SAMPLE PREP ASSISTANT III (BD SPA III)

Model Number 647205

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, tecan was notified by (b)(4) of an adverse event with the bd spa iii.Reference mfr report #2916837-2014-00001.A bd field service prep was repairing a bd spa iii at a customer site.The exit waste quick connect on the fluidics tower of the bd spa iii was broken.The male part of the fitting was jammed in the female part.The engineer proceeded to replace the female quick disconnect mounted in the fluidics tower.Decontamination of the system by the customer was not possible due to the failure mode.Upon cutting the tubing to the fluidic fitting, residual pressure in the waste tube sprayed biohazardous waste at the engineers face.The engineer was immediately taken to the accident and emergency department for a (b)(6) injection and immediate (b)(6) post-exposure prophylaxis and treatment continues.

Manufacturer Narrative

Tecan was notified of the adverse event by (b)(4) on (b)(6) 2014.(b)(4) indicated that the event was not a result of a malfunction of the instrument, but employee error in conducting the repair.No assistance or corrective action from tecan system was required by (b)(4).

• Brand Name: BD FACS SAMPLE PREP ASSISTANT III (BD SPA III)
• Type of Device: BD SPA III
• Manufacturer (Section D): TECAN SYSTEMS INC; 2450 zanker rd.; san jose CA 95131
• Manufacturer Contact: gary barron ; 2450 zanker rd.; san jose, CA 95131-7126 ; 4089533112
• MDR Report Key: 4060420
• MDR Text Key: 4866466
• Report Number: 2916719-2014-00001
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention