MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS ACT VIALED WHOLE BLOOD CONTROL; PLASMA, COAGULATION CONTROL

Model Number	QCACT
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot number provided by the customer was not valid.Therefore, the date of manufacture, lot number and expiry date are unknown.Process evaluation could not be performed.
Event or Problem Description
Occupational health nurse reported a needle stick injury sustained by an end user performing qc testing with a hemochron 801 act tube coagulation system.While withdrawing the qc material from the qcact vial, the needle slipped and punctured the end user's middle finger on her left hand.The end user squeezed the involved body part and washed it with soap and water three times.The end user also applied providone iodine.No additional management was administered by the occupational health nurse.
Additional Manufacturer Narrative
Lot number e7tca004.
Event or Problem Description
Follow-up #1.

• Brand Name: ACT VIALED WHOLE BLOOD CONTROL
• Common Device Name: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7325813
• Report Number: 2250033-2018-00005
• Device Sequence Number: 16169146
• Product Code: GGN
• UDI-Device Identifier: 10711234102206
• UDI-Public: 10711234102206
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K882481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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
• Operator of Device: Health Professional
• Device Model Number: QCACT
• Device Catalogue Number: QCACT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1