MAUDE Adverse Event Report: CARWILD CORP. NEURO PATTIE; GAUZE/SPONGE, INTERNAL

Catalog Number 30-054

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

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

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: medwatch report (b)(4) was received july 26, 2016, and entered as call (b)(4).According to the medwatch report, a neuro pattie became detached from its locator string and was unable to be located.The sponge is supplied to deroyal by (b)(4).As such, a supplier corrective action request (scar) was submitted to the supplier's manufacturing facility, (b)(4).The reporting customer has been contacted regarding sample availability.

Event Description

Neuro sponge was missing from the end of the attached string at completion of a surgical procedure.Room checked, surgical field searched.Special attention paid to surgical site, x-ray taken and the sponge was never located.In discussion with staff, it is reported these sponges become loose on string when they are saturated.What was the original intended procedure? l3-l5 revision, l5-s1 decompression.

Manufacturer Narrative

Root cause: the neuro pattie is supplied to deroyal industries, inc.By (b)(4).Therefore, a supplier corrective action request (scar) was submitted to (b)(4).In its scar response, the supplier stated the reported issue could happen due to the medical staff attempting to remove the pattie by the string.In the ifu, it states, "the string is attached to the sponge for location or identification purposes only.Do not use the string to remove the sponge from the wound." correction: in its scar response, (b)(4) stated all personnel involved (supervisor, group leader and collaborators) were notified about the reported issue for awareness during the process.Corrective action: a corrective action has not been taken.Investigation summary medwatch report (b)(4) was received july 26, 2016, and entered as (b)(4).According to the medwatch report, a neuro pattie became detached from its locator string and was unable to be located.The reporting customer returned a representative sample from the same lot for evaluation.Deroyal purchases the neuro patties from (b)(4).A scar and the sample returned by the customer were sent to (b)(4) for review.According to the scar, the supplier's investigation showed the work order was completed according to current procedure and customer requirements.Deroyal reviewed two cases of inventory.No cases from the reported lot number were available.Samples were counted to ensure proper count, pulled on, and soaked with saline then pulled on.No rejects were identified.Preventive action: a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

Neuro sponge was missing from the end of the attached string at completion of a surgical procedure.Room checked, surgical field searched.Special attention paid to surgical site, x-ray taken and the sponge was never located.In discussion with staff, it is reported these sponges become loose on string when they are saturated.What was the original intended procedure: l3-l5 revision, l5-s1 decompression.

• Brand Name: NEURO PATTIE
• Type of Device: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): CARWILD CORP.; 3 state pier rd.; 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: 5900639
• MDR Text Key: 52954393
• Report Number: 1060680-2016-00024
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• 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: 15E1947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 73 YR
• Patient Weight: 67