MAUDE Adverse Event Report: MEIXIN MEDICAL SUZHOU CO., LTD. 31-106 PEANUT SPONGE; GAUZE/SPONGE

Model Number	30-106
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause cannot be determined at this time.Corrective action: a replacement product was sent to the customer.A supplier corrective action request (scar) has been sent to the supplier (b)(4) investigation: returned product was not inspected.However, samples of the same product are being evaluated.A supplier corrective action request (scar) is being updated with further information before submitting it as 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
Shedding the blue xray detectable string during surgery.
Additional Manufacturer Narrative
Investigation finding: quality control inspected over the lot number.315 packs were inspected and no issues were found.It was found that the peanut sponges were properly placed on the holder foam as part of the inspection.In process inspection of 125 packs were randomly inspected and all were acceptable of the sponges placed correctly in the holder foam.(b)(4).Root cause: the peanut sponge is supplied to (b)(6) by (b)(4).Therefore, a supplier corrective action request (scar) was issued to (b)(4).The scar response from meixin medical checked the inventory items of the product (lot #ss2103b03) and shedding of the whole product was not found.It was found some products have too long xr string.The over long xr string will be just inside the outer layer of the sponge after the sponge forming, and it may easily come out after subsequent pressing or squeezing when the sponges are filled into the foam block for use.The subsequent inspection workers failed to find the over-hanging of the xr string.The current procedure does not require to inspect this problem.Corrective action: inspect sponges made by each worker to find the workers whose operation is not meeting standard.Correspondingly, retrain the worker and tighten the quality inspection on the manufacturing of products.If any loose sponges are found during the inspecting and packaging process, scrap the product immediately to ensure no nonconforming products are released.Preventive action: teach the intended purpose of the products to the workers to enhance their quality awareness.Verification: randomly inspect the quality of sponges during production to ensure they all meet product requirements and operation methods.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: 31-106 PEANUT SPONGE
• Common Device Name: GAUZE/SPONGE
• Manufacturer (Section D): MEIXIN MEDICAL SUZHOU CO., LTD.; no. 81 tuncun xi road; tuncun ind. zone; tongli town, wujiang district, suzhou 21521 6; CH 215216
• MDR Report Key: 11636058
• Report Number: 3010452421-2021-00005
• Device Sequence Number: 3697763
• Product Code: GDY
• UDI-Device Identifier: 00749756024280
• UDI-Public: 00749756024280
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: 30-106
• Device Lot Number: 51849274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• 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: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1