MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TR-MAJOR KIT

Catalog Number DYNJ54802B

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a breast reconstruction procedure the sponge frayed inside of the patient.The surgeon removed the sponge from the sterile field along with the pieces of the lap sponge from the operative space.There was no serious injury identified or follow up medical care required.There was no impact to the patient or the procedure being performed.General anesthesia was used however there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.The patient was discharged from the hospital and reported to be fine.A sample was returned for evaluation and the customer reported issue was confirmed.Due to the reported incident and in an abundance of caution, this medwatch is being filed.Should additional relevant information become available a supplemental report will be submitted.

Event Description

It was reported that during a procedure, pieces of the lap sponge frayed inside the patient.

• Type of Device: TR-MAJOR KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes dr.; northfield IL 60093
• Manufacturer (Section G): MEDLINE INDUSTRIES INC; three lakes dr.; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes dr.; northfield, IL 60093 ; 8476434960
• MDR Report Key: 7034898
• MDR Text Key: 93230911
• Report Number: 1423395-2017-00027
• 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: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ54802B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 119