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

Model Number QCACT

Device Problem Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 02/28/2018

Event Type  malfunction  

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 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.

Manufacturer Narrative

Lot number e7tca004.

Event Description

Follow-up #1.

• Brand Name: ACT VIALED WHOLE BLOOD CONTROL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• Manufacturer Contact: jon mcdermed ; 6260 sequence drive; san diego, CA 92121 ; 8582632490
• MDR Report Key: 7325813
• MDR Text Key: 101958991
• Report Number: 2250033-2018-00005
• Device Sequence Number: 1
• Product Code: GGN
• UDI-Device Identifier: 10711234102206
• UDI-Public: 10711234102206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QCACT
• Device Catalogue Number: QCACT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1