MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; APPLICATOR,COTTON-TIP,PLASTIC,6",STERILE

Catalog Number MDS202095

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that on an unspecified date the cotton tip of a sterile 6" plastic applicator came off/broke off inside a patient's incision during surgery.The reporter states the incision had to be extended to search for the sterile cotton tip.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.The sample has not been returned.Due to the reported nature of the incident, and the reported medical intervention this medwatch is being file.If additional relevant information becomes available, this report will be reopened and reevaluated.

Event Description

It was reported the tip of a sterile cotton tipped 6" plastic applicator came off inside a patient's incision during surgery.The incision had to be extended to search for cotton tip.

• Type of Device: APPLICATOR,COTTON-TIP,PLASTIC,6",STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10268220
• MDR Text Key: 201584131
• Report Number: 1417592-2020-00073
• Device Sequence Number: 1
• Product Code: KXG
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS202095
• Device Lot Number: 21619090001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/13/2020
• 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): Other; Required Intervention