MAUDE Adverse Event Report: MICROTEK DOMINICANA, S.A. PROBE DRAPE; PROBE COVER

Model Number	3787
Medical Device Problem Codes	Hole In Material (1293); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this report, no lot number or sample has been provided.No information has been received to indicate that the patient developed an infection.After evaluating the manufacturing processes, it was concluded that the non conformance could be related to machine, material or manpower but non of these hypothesis could be confirmed since the customer did not provide samples, pictures or lot number.Machine - the non conformance could be related to incorrect parameters set during the manufacturing process.This could not be confirmed because the dhr could not be reviewed to confirm the parameters used since no lot number was provided.Material - the probe cover and adhesive could be received defective from the supplier causing the non conformance reported by the customer.This could not be confirmed because the incoming inspection report could not be reviewed since no lot number was provided.Manpower - the training records could not be reviewed since the customer did not provide a lot number.It was concluded that the root cause of this event is undetermined and this investigation inconclusive.The manufacturing line was made aware of the non conformance reported by the customer.No further actions are being taken at this time.
Event or Problem Description
When using intraoperative prove cover on vascular ultrasound sterile probe cover separated while in use on patient.Surgeon notified and intraoperative bacitracin antibiotic was used for irrigation.

• Brand Name: PROBE DRAPE
• Common Device Name: PROBE COVER
• Manufacturer (Section D): MICROTEK DOMINICANA, S.A.; zona franca no. 2; la romana, ; DR
• MDR Report Key: 7522237
• Report Number: 8043817-2018-00016
• Device Sequence Number: 13799414
• Product Code: KKX
• UDI-Device Identifier: 00748426010370
• UDI-Public: (01)00748426010370
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K882724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: 3787
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1