MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BOOT,SUTURE,STANDARD,YELLOW-IN-BLUE

Catalog Number DYNJSBY5

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "product is falling apart while on the tips of instruments and falling into patients." due diligence has been completed.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.Due to the reported nature of the incident and in an abundance of caution, this medwatch is being filed.No samples have been returned for evaluation.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, "product is falling apart while on the tips of instruments and falling into patients.".

• Type of Device: BOOT,SUTURE,STANDARD,YELLOW-IN-BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 12163532
• MDR Text Key: 263414097
• Report Number: 1417592-2021-00117
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJSBY5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention