MAUDE Adverse Event Report: MEIXIN MEDICAL SUZHOU CO., LTD PNUT SP-PEEL-ST 5'S-250 SP/CS, X-RAY DETECTABLE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	30-106
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A distributer complaint was received on 11/22/2022 reporting, "the blue xray indicator on the peanut sponge is disintegrating during use.Patient was not injured but customer noted the risk of leaving foreign matter behind in the operative area if not corrected." a supplier corrective action request (scar) was sent to the supplier meixin medical.The investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information becomes available.
Event or Problem Description
The blue xtray indicator on the peanut sponge is disintegrating during use.Patient was not injured but customer noted the risk of leaving foreign matter behind in the operative area if not corrected.
Additional Manufacturer Narrative
A supplier corrective action request (scar) was sent to the supplier (b)(4).Root cause: it was determined that the x-ray filament that was used in the gauze may not have been as long as was required.Therefore, when the worker was coiling the gauze with the x-ray filament to form the sponge, the x-ray filament was stretched and its tensile strength was weakened which could lead to it disintegrating during use.The following corrective and preventive actions have taken place by meixin medical: to correct this issue, check operation method of all workers stressing that the x-ray filament should be in proper length and should not be over stretched.Correct on site immediately if any improper operation is noticed, stressing all workers' quality awareness to prevent occurrence of nonconformance.If any nonconforming sponges are detected during the inspecting and packaging process, scrap them as to ensure that all products meet quality requirement.To prevent further occurrences, train the workers to strictly follow the product diagram when making the specialty sponges.Stress that the x-ray filament should not be over stretched during coiling of the sponges.An inventory check of the sponges was made by deroyal, a total of (b)(4) packs were reviewed, and no discrepancies were identified during the inspection.Complaints were also reviewed by deroyal and it was found that from the past two years, of (b)(4) packs sold, 3 complaints were found relating to the performance of the product (b)(4).Each of these issues were related to vendor issues.Deroyal will continue to monitor for trends.This 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: PNUT SP-PEEL-ST 5'S-250 SP/CS, X-RAY DETECTABLE
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEIXIN MEDICAL SUZHOU CO., LTD; tuncan industrial zone; tongil town, wijiang; suzhou, jiangsu province 21521 6; CH 215216
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; canales zona 3; finca morancito, villa canales 01065 ; GT 01065
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19928469
• Report Number: 3010452421-2022-00001
• Device Sequence Number: 2846925
• Product Code: GDY
• UDI-Device Identifier: 00749756024280
• UDI-Public: 00749756024280
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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
• Device Model Number: 30-106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown