MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; SUTURE REMOVAL KIT

Lot Number	21BBM471
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of gastroesophageal reflux disease, anemia and recent diagnosis of cecal cancer underwent an ascending colectomy.Few weeks after, nurse experienced difficulty using the medline suture removal kit.The scissors and tweezers from the suture removal kit would not cut the sutures of a jackson-pratt drain.The scissors would not cut the sutures adequately.Scissors are thick at the hook and difficult to get under the suture.There is not a sharp edge to cut anything.The tweezers had a difficult time holding on to the sutures as they would not grasp well when squeezed.

• Brand Name: MEDLINE
• Common Device Name: SUTURE REMOVAL KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 12007907
• Report Number: 12007907
• Device Sequence Number: 19607086
• Product Code: MCZ
• UDI-Device Identifier: 10080196042807
• UDI-Public: (01)10080196042807(17)20230831(10)21BBM471
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/09/2021
• Report Date (Section F): 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 21BBM471
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 78
• Date Report Sent to FDA: 06/09/2021