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

Catalog Number DYNJ19701G

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

It was reported that during two different cases, gauze fibers came off of the raytec gauze and fell on to the patient and the surgical field.The fibers did not enter into an operative site.The fibers were manually removed.The raytec was removed from the field and replaced.We were provided limited details.No patient injury resulted.No further intervention was indicated.The actual samples were not retained for evaluation.Unused samples from the same lot were returned.We were unable to confirm the complaint with the returned samples.A root cause has not been determined.

Event Description

The facility reported that during two different cases, gauze fibers came off of the raytec gauze and fell on to the patient and the surgical field.

• Type of Device: LUMBAR LAMINECTOMY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5725735
• MDR Text Key: 47413369
• Report Number: 1423395-2016-00041
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ19701G
• Device Lot Number: 15LB2000,16MB1054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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): Other