MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-CATH LAB OHH

Catalog Number	DYNJ65554
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported lint was found inside the patient during a coronary intervention procedure.According to the customer, the coronary guide wires had to be removed after crossing lesion and post balloon angioplasty.It was reported no serious injury or follow-up care related to the patient incident.No additional information was available related to the event.The sample was received for evaluation.It is recommended to use a separate dedicated container for flush solution.Due to the reported need for medical intervention and in an abundance of caution, this is a mdr reportable event.If additional information becomes available a supplemental mdr will be filed.
Event or Problem Description
It was reported lint was found inside the patient during a coronary intervention procedure.

• Common Device Name: DBD-CATH LAB OHH
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10211673
• Report Number: 1423395-2020-00014
• Device Sequence Number: 19359871
• Product Code: OEQ
• UDI-Device Identifier: 10193489282443
• UDI-Public: 10193489282443
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ65554
• Device Lot Number: 20CBI454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR