MAUDE Adverse Event Report: MEDICAL ACTION (OWENS & MINOR); MEDICAL ACTION OR TOWEL IN HEART TRAY

Catalog Number	DYNJ44395C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unidentified procedure, the medical action or towel linted into the surgical site.After multiple good-faith attempts, the reporting facility was unable or unwilling to provide additional patient, product, or procedural information to the pack manufacturer.It is unknown if the reported linting occurred during first use of the medical action or towel, how the medical action or towel was being used at the time of the incident, or how the linted medical action or towel material was removed from the surgical site.No impact or adverse effect to the patient, the patient's stability, or the patient's plan of care was reported to the pack manufacturer.The or towel involved in the reported incident was discarded and not available to be returned to the pack manufacturer for evaluation.Medical action will be notified of the reported incident by the pack manufacturer.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an unidentified procedure, the medial action or towel linted into the surgical site.

• Common Device Name: MEDICAL ACTION OR TOWEL IN HEART TRAY
• Manufacturer (Section D): MEDICAL ACTION (OWENS & MINOR); 9120 lockwood boulevard; mechanicsville VA 23116 2015
• MDR Report Key: 8397799
• Report Number: 1423395-2019-00004
• Device Sequence Number: 14035005
• Product Code: LRO
• UDI-Device Identifier: 10889942927029
• UDI-Public: 10889942927029
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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 Catalogue Number: DYNJ44395C
• Device Lot Number: 18GBH694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/07/2019
• 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