MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DEVICE IMPLANT PACK (DIJEK)115; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN11DIJEL
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that during a biventricular pacemaker insertion, the towels pwtb04-stm from the san11dijel, device implant pack had an excessive amount of linting on the towels and physician¿s gloves.There was no delay and no adverse effect to the patient.
Additional Manufacturer Narrative
From the device history record, lot#20211117-23-sh was finished on nov 29, 2021.No exception was recorded in the device history record that could lead to the reported incident.From the supplier¿s investigation, the average linting data is 0.118g/10pcs.A sample was not available for investigation.A photo was provided for evaluation.No abnormal lint was seen on the towel.According to supplier, this is single use product.Or towel is made of cotton, so cotton fiber is born.Supplier is continuously working with cardinal health to better control the linting and has 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.(=0.38g/10pieces), 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.From the investigation, there is no abnormal situation in production or device history record.Therefore, the root cause could not be determined.We will continue to monitor trends for this product.

• Brand Name: DEVICE IMPLANT PACK (DIJEK)115
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15099148
• Report Number: 1423537-2022-00812
• Device Sequence Number: 5427859
• Product Code: OEQ
• UDI-Device Identifier: 10888439924725
• UDI-Public: 10888439924725
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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: SAN11DIJEL
• Device Catalogue Number: SAN11DIJEL
• Device Lot Number: 843425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/25/2022
• Date Device Manufactured: 05/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female