MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAMINECTOMY PACK

Catalog Number DYNJ17333G

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that during a laminectomy procedure the surgeon noticed the operating room (or) towel shedding lint into the surgical site which required irrigation to remove.There was no serious injury or follow-up care reported related to this event.There was no reported impact to the patient or to the laminectomy procedure.The patient was under general anesthesia during the event but it did not delay the laminectomy procedure.A sample was returned to the manufacturer for evaluation.The reported linting of the operating room (or) towel was confirmed.Due to the need for medical intervention this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that during a laminectomy procedure the surgeon noticed the operating room (or) towel shedding lint into the surgical site which required irrigation to remove.

• Type of Device: LAMINECTOMY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093 ; 2249311458
• MDR Report Key: 7286483
• MDR Text Key: 100604423
• Report Number: 1423395-2018-00005
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942286430
• UDI-Public: 10889942286430
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2018

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: Physician
• Device Catalogue Number: DYNJ17333G
• Device Lot Number: 17CD0319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention