MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. RAYTEK; CARDIOVASCULAR PROCEDURE KIT

Model Number	DYNJ04754L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During the initial count, the scrub nurse and circulating nurse counted 29 rayteks instead of 30 from the open heart pack b-lf (lot: 20amb676, exp: 04/30/2021, ref: dynj04754l).

• Brand Name: RAYTEK
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 11045664
• Report Number: 11045664
• Device Sequence Number: 19104353
• Product Code: OEZ
• UDI-Device Identifier: 10193489790764
• UDI-Public: 10193489790764
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2020
• Report Date (Section F): 11/18/2020

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: No Information
• Device Model Number: DYNJ04754L
• Device Catalogue Number: DYNJ04754L
• Device Lot Number: 20AMB676
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/18/2020