MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; NEURO BACK PACK-LF

Catalog Number DYNJ66797

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Email received by senior inventory clerk for surgical services, queen of the valley medical center, with additional information in regards to this complaint.Reporter confirms this incident occurred (b)(6) 2021 in the middle of a laminectomy procedure.Reporter further confirms, "large strands were coming loose from the gauze and needed to be removed that were on the incision." reporter state's, the frayed material was removed by hand by both the surgeon and technician.No serious injury or impact on the procedure had incurred.Reporter did not give an update as to how the patient is doing at this time.Samples are available for return and evaluation.Due to the reported incident, medical intervention and in an abundance of caution, a medwatch will be filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported large strands were coming loose from the gauze and needed to be removed from the incision.

• Type of Device: NEURO BACK PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11210374
• MDR Text Key: 229111803
• Report Number: 1423395-2021-00007
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10193489383027
• UDI-Public: 10193489383027
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ66797
• Device Lot Number: 20JKB868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR