MAUDE Adverse Event Report: MEIXIN MEDICAL SUZHOU CO., LTD. KITTNER (BLUNT) DISSECTOR; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	30-101
Medical Device Problem Codes	Material Disintegration (1177); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the sponge is supplied to deroyal by meixin medical.Therefore, a supplier corrective action request (scar) was issued to meixin.In its response, meixin stated when making the kittner sponges, some workers didn't sew the inner layers tightly enough or they didn't roll the cotton strip properly while sewing.Thus, the inserted x-ray may become exposed.Corrective actions: in its scar response, meixin stated it would check the operation method of workers making the kittner sponge and instruct them to correct improper operation, if any exists.Workers will be reminded to enhance quality awareness and strictly follow the work instruction to prevent occurrence of nonconformities.Additionally, if any loose kittner sponges are found during inspection and packaging process, these should be scrapped immediately to ensure no nonconforming products are released.Investigation summary: an internal complaint ((b)(4)) was received indicating a kittner sponge (part 30-101, lot 52709409) fell apart, leaving small radiopaque pieces behind in the patient.A picture of the affected product was provided and showed a small piece of radiopaque thread hanging from the sponge.A sample was returned but was contaminated and could not be evaluated.The work order and quality inspection report were reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.A total of 315 packs were randomly checked during qc inspection with no issues found.The sponge is supplied to deroyal by meixin medical.A scar was issued to meixin medical.A response was received january 26, 2021 and accepted by deroyal personnel.The investigation is complete.If new and critical information is received, this report will be updated.
Event or Problem Description
The kittner sponge is coming apart and leaving small radiopaque pieces in the patient.

• Brand Name: KITTNER (BLUNT) DISSECTOR
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEIXIN MEDICAL SUZHOU CO., LTD.; no. 81 tuncun xi road; tuncun ind. zone, tongli town; wujiang district, suzhou, jiangsu 21521 6; CH 215216
• MDR Report Key: 11279846
• Report Number: 3010452421-2021-00001
• Device Sequence Number: 4162794
• Product Code: GDY
• UDI-Device Identifier: 50749756024391
• UDI-Public: 50749756024391
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 30-101
• Device Lot Number: 52709409
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1