MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE HEART CATHETER PACK (HCSBC)180; GENERAL SURGERY TRAY (KIT)

Model Number	SANHFHCSBD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number 20200220-23-sh was manufactured on 02/28/2020.No exception was recorded in the device history record that could lead to the reported incident.The linting test data was within the acceptable range, therefore, the root cause could not be determined from this investigation.At the time of this investigation the sample had not been returned to cardinal health.The complaint information was informed to the relevant personnel for their awareness.There is no action taken at this time, however, we will continue to monitor the trend of this type of incident.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier 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.(=0.38 g/10 pieces).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.
Event or Problem Description
Based on information received from the customer the pack reportedly contained towels with excess lint.Allegedly on the most recent occasion, the physician was intervening, and towel lint was found inside the tuohy needle.
Additional Manufacturer Narrative
Based on supplier investigation, device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.156 g / 10 pieces.From the investigation, there is no abnormal situation happened in production.Photos were provided for evaluation.The sample of or towel was packed in a bag, and no abnormal situation was found.Therefore, the root cause could not be determined.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier continuously working with cah to better control the linting and have implemented several measures to improve it: a.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38 g/10 pieces).D.In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.

• Brand Name: HEART CATHETER PACK (HCSBC)180
• Common Device Name: GENERAL SURGERY TRAY (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: 10148911
• Report Number: 1423537-2020-00467
• Device Sequence Number: 3610921
• Product Code: LRO
• UDI-Device Identifier: 10888439335026
• UDI-Public: 10888439335026
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: SANHFHCSBD
• Device Catalogue Number: SANHFHCSBD
• Device Lot Number: 424409
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other