MAUDE Adverse Event Report: JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD. CYLINDRICAL SPONGE; GAUZE/SPONGE

Model Number	30-045
Medical Device Problem Codes	Radiation Output Problem (4026); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per customer information no patient injury occurred.Root cause cannot be determined at this time.Investigation: due to the product not being returned by the customer, no inspection was performed.A supplier corrective action request (scar) has been filed and sent to the supplier (gd medical) to be completed.The investigation is incomplete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
Radiopaque cottonwood sponge did not show up on x-ray.
Additional Manufacturer Narrative
Investigation finding: a total of 436 units have been sold from march 2019 to present with a sales/complaint ratio of 0.002294, during this time this is the only complaint for this product.A supplier corrective action request (scar) was sent and completed by the supplier (gd medical).Supplier's response to the x-ray filaments used in the device was verified to be effective.Root cause: an isolated human error during the manufacturing process could be a potential root cause.Corrective action: supervisor over the sponge production workshop is notified of the incident.Quality assurance will pay closer attention to the issue during in-process and finished product inspections to avoid occurence.Preventive action: when receiving raw x-ray filaments material, x-ray testing will be conducted to ensure effectiveness.The investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: CYLINDRICAL SPONGE
• Common Device Name: GAUZE/SPONGE
• Manufacturer (Section D): JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD.; 18 baochang road north; haian 22663 1; CH 226631
• MDR Report Key: 11637185
• Report Number: 1060680-2021-00002
• Device Sequence Number: 19567125
• Product Code: GDY
• UDI-Device Identifier: 00749756028332
• UDI-Public: 00749756028332
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: 30-045
• Device Lot Number: 19082732
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5099265
• Patient Sequence Number: 1