MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CARD,LOAD RECORD,STERILIZATION

Catalog Number MDS200600

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/23/2023

Event Type  Injury  

Manufacturer Narrative

The customer reported an infection.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was requested to be returned for evaluation.No additional information is available.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Reported infection due to sterilization indicator.

Manufacturer Narrative

Updated with information gathered due to sample being returned.Lot number and sample information was updated.

• Type of Device: CARD,LOAD RECORD,STERILIZATION
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17163623
• MDR Text Key: 317628324
• Report Number: 1417592-2023-00254
• Device Sequence Number: 1
• Product Code: LRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MDS200600
• Device Lot Number: 230201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other