MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE INDUSTRIES, INC.; DBD-TR-MAJOR KIT-LF

Model Number DYNJ54802C

Device Problem Material Frayed (1262)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, "lap sponges are fraying in pack" and the "cotton thread/string stuck to the patient/incision." 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 been requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, "lap sponges are fraying in pack" and the "cotton thread/string stuck to the patient/incision.".

Manufacturer Narrative

According to the customer, "threads had to be removed from tissue using forceps".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: DBD-TR-MAJOR KIT-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16674947
• MDR Text Key: 312629899
• Report Number: 1423395-2023-00015
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942894499
• UDI-Public: 10889942894499
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ54802C
• Device Catalogue Number: DYNJ54802C
• Device Lot Number: 22LDA140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other