MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. DYNJ CUSTOM PACK; SURGICAL PACK

Catalog Number DYNJ54802B

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2017

Event Type  malfunction  

Event Description

During the procedure, the surgeon noted that a piece of the 18x18 had frayed.She removed it and the sponge from the sterile field.The procedure was completed as planned with no harm to the patient.Per site reporter: this is an ongoing issue that is reported directly to our sales representative.

• Brand Name: DYNJ CUSTOM PACK
• Type of Device: SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7040410
• MDR Text Key: 92353246
• Report Number: 7040410
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ54802B
• Device Lot Number: 17GD0664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 68