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

Model Number SCV21IMNSC

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

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 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 pacemaker drape a29013an 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.

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.No exception was recorded in the device history record (dhr) that could lead to the reported incident.All quality assurance testing performed during the manufacturing process was acceptable and met all specification requirements.A sample was not available for investigation.Therefore, the root cause could not be determined.Cardinal will continue to monitor complaint trends for this product.

• Brand Name: IMPLANT PACK (IMNSB)177
• Type of Device: 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 birchwoood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15447582
• MDR Text Key: 300576837
• Report Number: 1423537-2022-00843
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 10195594677244
• UDI-Public: 10195594677244
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/30/2022
• Date Device Manufactured: 05/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1