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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

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.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 Description

The kittner sponge is coming apart and leaving small radiopaque pieces in the 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 ; GT
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 11279846
• MDR Text Key: 243128606
• Report Number: 3010452421-2021-00001
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 52709409
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: No
• 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