MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAP SPONGE AND PITCHER IN MAJOR ORTHO PACK

Catalog Number	DYNJ52304B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during the set-up of an unidentified procedure, foreign particulate was found on a lap sponge and inside of a pitcher.Reportedly, the unidentified procedure was cancelled and the patient was required to return to have it completed.After multiple good-faith attempts, the facility contact remains unable or unwilling to provide additional patient, product, or procedural information.The manufacturer received the reported particulate taped onto a sticky note.Neither the lap sponge nor the pitcher were returned to the manufacturer for evaluation.Without a physical sample the manufacturer could not confirm the particulate or its location within the reported pack.A root cause could not be determined.No serious injury, impact to the patient's stability and plan of care, or follow-up care was reported.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 the set-up of an unidentified procedure, foreign particulate was found on a lap sponge and inside of a pitcher.Reportedly, the unidentified procedure was cancelled and the patient was required to return to have it completed.

• Common Device Name: LAP SPONGE AND PITCHER IN MAJOR ORTHO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7734581
• Report Number: 1423395-2018-00040
• Device Sequence Number: 16789465
• Product Code: OJH
• UDI-Device Identifier: 10889942830329
• UDI-Public: 10889942830329
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ52304B
• Device Lot Number: 18EB0584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/31/2018
• 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: Other