MAUDE Adverse Event Report: CARWILD CORPORATION NEURO SPONGES; GAUZE/SPONGE, INTERNAL

Catalog Number 30-054

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

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

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

Root cause analysis: (b)(4) supplies the neuro sponges, which are manufactured at its (b)(4) facility.In its response to deroyal's supplier corrective action request (scar), (b)(4) stated the true root cause could not be determined.A potential cause could to be related to end user handling, such as excessive handling or sharp instruments coming into contact with the non-woven material during use.Material inspections, in-process, and finished good evaluations identified material integrity was maintained.The lot number (14j1243) provided by the customer does not match part number 30-054 or the neuro sponge product line.Because the lot could not be traced, rejected trends of 2014 for all lots of 30-054 were reviewed.No evidence of "fuzzy" defects was found.The neuro sponge is a non-woven textile fabric.Therefore, any sharp tools or cutting devices could damage the sponge, or any small protruding parts could snag the sponge.Excessive handling may cause fibers from the non-woven sponge material to disassociate.Corrective action and/or systemic correction action taken: in its scar response, (b)(4) determined no corrective actions are to be implemented because no material or manufacturing issues could be detected.Investigation summary a (b)(4) was received indicating that a neuro sponge (part number 30-054, lot number 14j1243) was "leaving fuzz on the surface." (b)(4) supplies the neuro sponge, which is manufactured at its (b)(4) facility.The qc complaint specialist reviewed the 2013-2015 scar and supplier notification letter (snl) logs for similar complaints.In 2013, a similar complaint was identified that the finished good left debris during a procedure.Scar2015-322kjg was issued to (b)(4) to address this complaint, and a response was received 10/2/2015.In the scar response, the supplier identified that the lot number reported is not a valid lot number for the product.(b)(4).Preventive action: in its scar response, the supplier has indicated awareness of this issue will be documented to personnel associated with this product.

Event Description

Doctor was concerned due to the product leaving fuzz on the surface.Fuzz was visible only under the microscope.

• Brand Name: NEURO SPONGES
• Type of Device: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): CARWILD CORPORATION; 3 state pier road; new london CT 06320
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5185121
• MDR Text Key: 29804239
• Report Number: 1060680-2015-00043
• Device Sequence Number: 1
• Product Code: EFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791871
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30-054
• Device Lot Number: 14J2143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: No
• 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