MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC IMPLANT PACK (IMNSB)177; CARDIOVASCULAR PROCEDURE KIT

Model Number	SCV21IMNSC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that during a permanent pacemaker placement, there was linting within the implant pack scv21imnsc.Customer is unsure the source but states possibly from the cotton towels pwtb04-stm since the guide wire was on the drape with a wet towel on top to keep the wire from jumping off the table.There was no adverse effect reported.
Additional Manufacturer Narrative
Supplemental report is being filed following the submission of the initial mdr report that was submitted on 9/19/2022, due to the investigation findings are available.From the device history record, lot #20220128-23-sh was finished on march 22, 2022.No exception was recorded in the device history record (dhr) that could lead to the reported incident.The average linting data is 0.128g/10pcs.A sample was not available for investigation.Photo was provided which showed blue lint on the guide wire.According to the supplier, the or 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: suction 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 (sop) requirement, linting test method and acceptable criteria was stipulated to see the suction results at (=0.38g/10pieces), and in the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting sticking onto the products during product's transfer.From the investigation, no abnormal situation happened in production or device history record.Therefore, the root cause could not be determined.Cardinal will continue to monitor complaint trends for this product.

• Brand Name: IMPLANT PACK (IMNSB)177
• Common Device Name: CARDIOVASCULAR PROCEDURE 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: 15447556
• Report Number: 1423537-2022-00842
• Device Sequence Number: 11944363
• Product Code: OEZ
• UDI-Device Identifier: 10195594677244
• UDI-Public: 10195594677244
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: SCV21IMNSC
• Device Catalogue Number: SCV21IMNSC
• Device Lot Number: 856741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/19/2022
• Date Device Manufactured: 05/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown