MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; MP NEURO PACK

Model Number DYNJ49951J

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility the 'raytec gauze were coming apart and leaving fragments in the patient which had to be manually retrieved'.Per the facility the fragments were noticed in the beginning and the middle of the procedure.The fragments were manually retrieved and removed from the patient and the product was removed from the field and replaced with another.According to the facility the procedure was completed after extended surgical time, and there was no reports of serious injury to the patient.The sample was requested to be returned for evaluation but was not available.No additional information is available.Due to the reported incident and 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 facility the 'raytec gauze were coming apart and leaving fragments in the patient which had to be manually retrieved'.

• Brand Name: Medline Industries, Inc.
• Type of Device: MP NEURO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14187143
• MDR Text Key: 289951473
• Report Number: 1423395-2022-00014
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10193489857627
• UDI-Public: 10193489857627
• 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
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ49951J
• Device Catalogue Number: DYNJ49951J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 85 KG