MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-25 for TOWEL OR 17X24IN BLUE STERILE 4/PK 28700-004 manufactured by Jianerkang Medical Dressing Co, Ltd.
[134640937]
At the time of this investigation the device history record could not be verified, as a lot number was not provided. However, (b)(4) (supplier) checked on the device history record for the past 2 years and did not find any linting data 0. 38g/10pieces. A sample was not provided for evaluation, but our blue or towel is classified as a? Low lint cotton or towel? And since the towel is made of cotton, some lint is inevitable. Our supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process. The suction process has been added before the product's final folding, and workers do it according to standard operation procedure requirement. Linting test method and acceptable criteria has been stipulated to see the suction results. (=0. 38g/10pieces). In the folding process, our supplier uses one cloth pad under 100 pieces semi-finished products to avoid linting being stuck onto the products during product's transfer. Based on the investigation, there is no abnormal situation noted that may have happened in production and all linting test data were within the acceptable range. Therefore, the root cause could not be determined. The complaint information was informed to the relevant sectors for their awareness. There is no other action taken at this time, however, our supplier will continue to monitor the trend of this type of incident.
Patient Sequence No: 1, Text Type: N, H10
[134640938]
Based on information received from the hospital representative, the lint from the cardinal health sterile towels is reportedly getting onto other product during cases. During a case in their cath lab, lint was reportedly found on a guidewire that would be inserted into the patient. Per the hospital representative, there was no injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00254 |
| MDR Report Key | 8276947 |
| Date Received | 2019-01-25 |
| Date of Report | 2019-04-10 |
| Date of Event | 1980-01-01 |
| Date Facility Aware | 2019-01-03 |
| Date Mfgr Received | 2019-01-03 |
| Date Added to Maude | 2019-01-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | JIANERKANG MEDICAL DRESSING CO, LTD |
| Manufacturer Street | NO.1, JIAN ER KANG ROAD, ZHIXI JIANGSU PROVINCE |
| Manufacturer City | JINTAN CITY 213251 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 213251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TOWEL OR 17X24IN BLUE STERILE 4/PK |
| Generic Name | GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2019-01-25 |
| Model Number | 28700-004 |
| Catalog Number | 28700-004 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANERKANG MEDICAL DRESSING CO, LTD |
| Manufacturer Address | NO.1, JIAN ER KANG ROAD, ZHIXI JIANGSU PROVINCE JINTAN CITY 213251 CH 213251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-25 |