MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (NPOLF)367; GENERAL SURGERY TRAY (KIT)

Catalog Number	SNECNNPOLG
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the or towel (catalog# pwtb04-stm) in their neuro pack (catalog# snecnnpolg) appeared to be ¿linty¿ during a microdiscectomy.Manual removal and irrigation were needed which led to a ten minute delay in the procedure.No adverse effects to the patient are known at this time.The lot number was provided, and the supplier¿s review of the device history record did not indicate any exception that could lead to the reported incident.The average linting data is 0.222g / 10 pieces.No sample was available for investigation, only a photo of the sample (with one loose thread) was provided.The supplier determined that is acceptable according to their sampling criteria.The or towel is made of cotton, so lint is inborn and inevitable.The measures used to control and improve linting include: a.Suctions machines are installed in the cloth rolling process, dyeing process and cutting process b.The suction process was added before the product's final folding, and workers do it according to standard operation procedure requirements.C.Linting test method and acceptable criteria are stipulated to see the suction results (=0.38g/10 pieces).D.In the folding process, one cloth pad is under/protects 100 pieces semi-finished product to avoid lint sticking during product transfer.Based on the investigation, the root cause could not be determined and no action will be taken at this time the complaint information was shared with the relevant sectors for their awareness, and we will continue to monitor complaints for this type of incident.
Event or Problem Description
The customer reported that the or towel (catalog# pwtb04-stm) in their neuro pack (catalog# snecnnpolg) appeared to be ¿linty¿ during a microdiscectomy.Manual removal and irrigation were needed which led to a ten minute delay in the procedure.No adverse effects to the patient are known at this time.

• Brand Name: NEURO PACK (NPOLF)367
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 8823391
• Report Number: 1423537-2019-00336
• Device Sequence Number: 2859665
• Product Code: LRO
• UDI-Device Identifier: 10888439382891
• UDI-Public: 10888439382891
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: SNECNNPOLG
• Device Lot Number: 191685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR