MAUDE Adverse Event Report: BREA DISCRETE MFG IO GENERIC CONNECTION UNIT (NCCLS); RADIOASSAY, VITAMIN B12

Model Number GENERIC CONNECTION UNIT (NCCLS)

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Concussion (2192)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

No patient involvement.User was injured while performing routine troubleshooting.The user reported visiting the employee health centre with headache, nausea and a bump.There was no blood loss, and the clinic diagnosed the user with a concussion.The user was cleared to return to work the next day.No further information is available regarding prescribed treatment or medication.Based on the information provided by the user, it determines that the user failed to follow instructions for use (ifu) regarding touching the instrument while in use.Per power processor generic/idc and dxi connection modules ifu (instruction for use), document id (b)(4), moving parts label indicates moving parts that can pinch or crush.¿this label is found in several locations.Caution parts move automatically.While the system is in operation, do not touch or go close to any moving parts.Close protective guards and covers during operation.Failure to close covers correctly can cause injury or incorrect results.¿ the failure mode was confirmed to be use error.(b)(4).

Event Description

The user reported a head injury due to use error.While the user was receiving troubleshooting directions on the phone from customer technical support (cts), a different user not under the instruction of cts, was on the floor unplugging the barcode reader spinner motor.As the user tried to get up off the floor, they reported using the track to steady themselves.The force led the track to jiggle and for the door to the generic connection sampling cover to fall down on the user's head.The injured user reported visiting the employee health centre with headache, nausea and a bump.There was no blood loss, and the clinic diagnosed the user with a concussion.The user was cleared to return to work the next day.No further information is available regarding prescribed treatment or medication as a result of this event.The cts reported visiting the customer site the following day after the incident and confirmed no loose parts in the product associated with the event.

• Brand Name: GENERIC CONNECTION UNIT (NCCLS)
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BREA DISCRETE MFG IO; 250 s kraemer blvd; brea CA 92821 8000
• Manufacturer (Section G): BREA DISCRETE MFG IO; 250 s. kraemer blvd; brea CA 92821 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8931293
• MDR Text Key: 155529186
• Report Number: 2050012-2019-01100
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590589561
• UDI-Public: (01)15099590589561(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2019

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: Health Professional
• Device Model Number: GENERIC CONNECTION UNIT (NCCLS)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/26/2019
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other