MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CRANE CENTER HAND PACK-LF

Catalog Number	DYNJ0041795C
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that an increase in surgical site infections was identified at the reporting facility over the 2019 calendar year.Reportedly, a preliminary investigation by the reporting facility identified the surgical pack as one of the products utilized.After multiple good faith attempts the reporting facility was unable or unwilling to provide additional patient, product, component, or procedural information to the pack manufacturer.No sample was returned to the pack manufacturer.A root cause for the reported incident was unable to be determined.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 an increase in surgical site infections was identified at the reporting facility.

• Common Device Name: CRANE CENTER HAND PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9224546
• Report Number: 1423395-2019-00042
• Device Sequence Number: 1891808
• Product Code: LRO
• UDI-Device Identifier: 10889942846665
• UDI-Public: 10889942846665
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

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: DYNJ0041795C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/23/2019
• 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: Other