MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-31 for KITTNER (BLUNT) DISSECTOR 30-101 manufactured by Meixin Medical Suzhou Co., Ltd..
[59363335]
Investigation summary medwatch report (b)(4) was received reporting a kittner sponge (part number 30-101, lot not provided) contained a radiopaque thread that was shredding from the sponge when in use. An internal complaint (call (b)(4)) was opened to investigate this report. A lot number was not reported; therefore, process records could not be reviewed. A sample was reported to be available; however, as of the date of this report, it has not been received. Efforts are ongoing to retrieve the sample a total of (b)(4) packs for the referenced part number have been sold from 2014 to present. A total of (b)(4) incidents, including this complaint, have been reported for the same time period. No finished goods utilizing the same raw material sponge have reported similar issues. The raw material sponge is supplied to deroyal by (b)(4). The investigation is incomplete at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[59363336]
Event desc. : surgeon noted radiopaque thread shredding from kittner sponge when in use. Note: request made for company rep contact information. What was the original intended procedure? Thyroidectomy device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
[65925514]
Root cause: based on the evaluation of the complaint sample, the root cause was determined to be a vendor related issue. A supplier corrective action request (scar) was issued to the supplier, (b)(4). In its response, (b)(4) stated that some employees did not fully understand the quality requirement for the dissectors and failed to remove nonconforming product defected with the reported quality issue. Corrective action: in its scar response, (b)(4) stated that workers have been retrained on the quality product standard. Additionally, inspection is being performed of the operation at output product work sites to ensure conformity and full inspection of finished good inventory to remove non-conforming product. Investigation summary medwatch report (b)(4) was received reporting a kittner sponge (part number 30-101, lot not provided) contained a radiopaque thread that was shredding from the sponge when in use. An internal complaint (b)(4) was opened to investigate this report. A lot number was not reported; therefore, process records could not be reviewed. A sample was received november 4, 2016. The sample was evaluated november 29, 2016, after decontamination. Lot number 42325989 was identified on the sample received. Inventory evaluation was performed and showed similar issues to the complaint sample. (b)(4) supplies the dissectors to deroyal. Therefore, a scar was issued to (b)(4). The response was accepted december 19, 2016. During manufacturing for the lot number referenced, there were (b)(4) foam holders that were detected as defective. These defective units were removed and replaced with new inventory. Quality control inspection of the lot number referenced does not show any issues that may have contributed to the reported event. A total of (b)(4) packs out of (b)(4) total packs of the work order were inspected. A total of (b)(4) packs of the part in reference have been sold from january 2, 2015, to january 3, 2017. During the same time frame, no issues other than the referenced complaint have been reported. No other finished goods using the same raw material number have reported similar issues. Preventive action: a preventive action has not been taken. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[65925515]
Event desc. : surgeon noted radiopaque thread shredding from kittner sponge when in use. Note: request made for company rep contact information. What was the original intended procedure? Thyroidectomy. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010452421-2016-00021 |
| MDR Report Key | 6067233 |
| Date Received | 2016-10-31 |
| Date of Report | 2017-01-12 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2016-09-27 |
| Date Added to Maude | 2016-10-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELIZABETH REED |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621256 |
| Manufacturer G1 | ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | VILLA CANALES GUATEMALA, 01065 |
| Manufacturer Country | GT |
| Manufacturer Postal Code | 01065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KITTNER (BLUNT) DISSECTOR |
| Generic Name | GAUZE/SPONGE, INTERNAL |
| Product Code | EFQ |
| Date Received | 2016-10-31 |
| Returned To Mfg | 2016-11-04 |
| Model Number | 30-101 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEIXIN MEDICAL SUZHOU CO., LTD. |
| Manufacturer Address | NO. 81 TUNCUN XI ROAD TUNCUN IND. ZONE TONGLI TOWN, SUZHOU JIANGSU 215216 CH 215216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-31 |