MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. NEURO SPONGE; GAUZE/SPONGE, INTERNAL

Model Number	30-057
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call 48625) was received for a neuro sponge (part 30-057, lot 19051556) on which the string was not completely attached.The end user discarded the defective sample.However, a representative sample from the same lot was returned.No issues were identified with the representative sample.All strings were intact.The work order for the reported lot was reviewed for possible discrepancies that may have contributed to the event.No discrepancies were identified.The sponge is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was issued to the vendor.As of the date of this report, a response has not been received.The instructions for use included with this product specify the string is not meant for retrieval of the neuro sponge and only for detection.A total of (b)(4) units have been sold from (b)(6) 2017 to the present with a complaint-to-sales ratio of (b)(4).During this time frame, there were six complaints.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
The surgeon noticed the string was not completely attached to the sponge.Another pack was opened and the string easily came off the sponge.
Additional Manufacturer Narrative
Root cause: the neuro sponge is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was issued to (b)(4).In its response, the supplier stated the following: 1) the investigation did not show that manufacturing was the root cause of the reported failure.The dhr was reviewed and all product samples met the established acceptance criteria.There is no history of string-sponge separation for parts prior to use in surgery.There have been no changes to the materials, product design, manufacturing processes or procedures; 2) the root cause is "undetermined" because there is no evidence with the subject lot or historically to suggest manufacturing is the cause of the reported failure mode; 3) one potential and common root cause for the string detachment defect is associated with improper use of the device.The string is intended for location (counting) purposes only, but is very often used for removal of sponge from site.There is a warning on the ifu and printed directly on the winding card regarding this.Corrective action: due to the root cause determination, a corrective action has not been implemented.Investigation summary: an internal complaint ((b)(4)) was received for a neuro sponge (part 30-057, lot 19051556) on which the string was not completely attached.The end user discarded the defective sample.However, a representative sample from the same lot was returned.No issues were identified with the representative sample.All strings were intact.The work order for the reported lot was reviewed for possible discrepancies that may have contributed to the event.No discrepancies were identified.The sponge is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was issued to the vendor.A response was received and accepted by deroyal personnel december 16, 2019.The instructions for use included with this product specify the string is not meant for retrieval of the neuro sponge and only for detection.(b)(4).The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
The surgeon noticed the string was not completely attached to the sponge.Another pack was opened and the string easily came off the sponge.

• Brand Name: NEURO SPONGE
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial; san pedro de macoris; san pedro de macoris, ; DR
• MDR Report Key: 9445832
• Report Number: 1060680-2019-00010
• Device Sequence Number: 2219155
• Product Code: EFQ
• UDI-Device Identifier: 00749756035910
• UDI-Public: 00749756035910
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K791871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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 Model Number: 30-057
• Device Lot Number: 19051556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1