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

Model Number 30-101

Device Problems Material Disintegration (1177); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: the sponge is supplied to deroyal by meixin medical.Therefore, a supplier corrective action request (scar) was issued to meixin medical.In its response, the supplier stated some workers keep the end of the x-ray filament too long when making the kittner sponge.The end of the filament may come out of the sponge.During subsequent inspection and packaging, workers notice the long end of the filament and may try to trim it.The trimmed ends may be left on the sponge.Corrective action: in the scar response, meixin medical listed the following corrective actions: 1) check the operation method of all workers making kittner sponges and instruct them to correct improper operation if any.Remind workers to enhance quality awareness, and stress that they strictly follow the work instruction diagram to prevent occurrence of non-conformities.2) if any non-conforming products are found during inspection and packaging, the product should be scrapped rather than trimmed to prevent potential foreign debris.Investigation summary an internal complaint ((b)(4)) was received indicating a kittner sponge (part 30-101, lot 51774655) failed during use.Specifically, the radiopaque strip detached from the sponge.No samples and pictures of the reported issue are available.The device history record was reviewed for potential issues that may have contributed to the reported event.None were found.The qc inspection check also was reviewed.A total of 315 packs were randomly checked with no issues found.Based on the information provided, it was determined this issue was not related to deroyal's assembly process.Therefore, a scar was issued to the sponge manufacturer, meixin medical.A response to the scar was received december 23 and accepted by deroyal personnel.A work in process inspection was performed with 125 packs randomly checked.No issues were found.All kittners were properly placed in the foam holders.No x-ray elements were sticking out.An inventory check also was performed with four cases of product randomly checked.No issues were found.Over the last 2 years, (b)(4) cases of 30-101 have been sold.During the same time period, no similar events have occurred, yielding a complaint-to-sales percentage of (b)(4).The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The sponge's radiopaque strip becomes detached and may be left in wound.The sponge creates fibers, which can be left in patient.

• Brand Name: KITTNER (BLUNT) DISSECTOR
• Type of Device: 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
• Manufacturer (Section G): ORTHO AND SURGICAL ENTERPRISES S.A.; km 20.5 carretera a villa cana; zona 3 finca morancito; villa canales, guatemala 01065 ; GT 01065
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 11134136
• MDR Text Key: 239468491
• Report Number: 3010452421-2020-00004
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 50749756024391
• UDI-Public: 50749756024391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30-101
• Device Lot Number: 51774655
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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