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

Catalog Number DYNJ54802B

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  malfunction  

Event Description

It was noticed during a case that pieces of the 18x18 lap sponge frayed and were found in the patient.The sponge was removed from the sterile field.No harm occurred to the patient.

• Brand Name: CUSTOM DYNJ PACK
• Type of Device: CUSTOM DYNJ PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6964594
• MDR Text Key: 89825929
• Report Number: 6964594
• 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: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ54802B
• Device Lot Number: 17GD0664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 67 YR
• Patient Weight: 119