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

Catalog Number SNECNNPOLG

Device Problem Material Integrity Problem (2978)

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

Event Date 06/24/2019

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 8823391
• MDR Text Key: 164255571
• Report Number: 1423537-2019-00336
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439382891
• UDI-Public: 10888439382891
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SNECNNPOLG
• Device Lot Number: 191685
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2019
• Date Device Manufactured: 01/15/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR