MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE PEDIATRIC OPEN HEART PACK (OHOFD)644; CARDIOVASCULAR PROCEDURE KIT

Model Number	SCV43OHOFD
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot#20200403-23-sh was finished on 06th may 2020 and lot#20191227-23-sh was finished on 26th dec 2019.No exception was recorded in the device history record that could lead to the reported incident.The average linting data are 0.167g/(b)(4) and 0.171g/10pcs.No sample was available for investigation, only photos were provided.There is blue lint found on the surface of the instrument and there is no lint on the surface of the towel.According to supplier, operating room towel is made of cotton, so cotton fiber is born.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 was added before product's final folding, and workers do it according to standard operation procedure requirement, linting test method and acceptable criteria was stipulated to see the suction results.(b)(6), in the folding process, supplier used one cloth pad under (b)(4) semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, no abnormal situation happened in production or dhr.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported that blue towels pwtb04-stm from the pediatric open heart kit scv43ohofd were faded and shedding quite a lot of lint.No further information or demographics were provided at the time of this report.

• Brand Name: PEDIATRIC OPEN HEART PACK (OHOFD)644
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 11720642
• Report Number: 1423537-2021-00625
• Device Sequence Number: 14251382
• Product Code: OEZ
• UDI-Device Identifier: 10888439906776
• UDI-Public: 10888439906776
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCV43OHOFD
• Device Catalogue Number: SCV43OHOFD
• Device Lot Number: 520794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other