MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETER, PERITONEAL

Catalog Number DYND50422

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2022

Event Type  malfunction  

Event Description

We were doing an inguinal hernia repair, we were using a penrose drain for retraction and the penrose drain broke in two.All pieces were retrieved there was nothing left in and patient was not harmed.

• Brand Name: MEDLINE
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 16310982
• MDR Text Key: 308938111
• Report Number: 16310982
• Device Sequence Number: 1
• Product Code: GBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND50422
• Device Lot Number: 6051901002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9855 DA
• Patient Sex: Male
• Patient Weight: 106 KG