TOWEL OR 17X24IN BLUE STERILE 4/PK 28700-004

MAUDE Adverse Event Report

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.

Event Text Entries

[134368562] 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


[134368564] Based on information received from the hospital representative, lint from the cardinal health sterile towels is reportedly getting onto other product during cases. Per the hospital representative, there was no injury to patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423537-2019-00256
MDR Report Key8276904
Date Received2019-01-25
Date of Report2019-04-10
Date of Event1980-01-01
Date Facility Aware2019-01-03
Date Mfgr Received2019-01-03
Date Added to Maude2019-01-25
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPATRICIA TUCKER
Manufacturer Street3651 BIRCHWOOD DRIVE
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478874151
Manufacturer G1JIANERKANG MEDICAL DRESSING CO, LTD
Manufacturer StreetNO.1, JIAN ER KANG ROAD, ZHIXI JIANGSU PROVINCE
Manufacturer CityJINTAN CITY 213251
Manufacturer CountryCH
Manufacturer Postal Code213251
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTOWEL OR 17X24IN BLUE STERILE 4/PK
Generic NameGAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
Product CodeNAB
Date Received2019-01-25
Model Number28700-004
Catalog Number28700-004
Lot NumberUNKNOWN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerJIANERKANG MEDICAL DRESSING CO, LTD
Manufacturer AddressNO.1, JIAN ER KANG ROAD, ZHIXI JIANGSU PROVINCE JINTAN CITY 213251 CH 213251


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-25

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