MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 28FR

Model Number	8888561068
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported 1 green trocar catheter had only a needle in the package and no drain.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported 1 green trocar catheter had only a needle in the package and no drain.
Additional Manufacturer Narrative
A device history record (dhr) review could not be completed as no lot number details were available.The complaint report indicates that no sample is available in connection with this complaint because it was discarded.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).If a sample should be returned at a later date, this complaint will be reopened, and the investigation updated to reflect our findings.Unfortunately, without a sample we are unable to confirm the reported condition.The associated data will be fed into the risk management quarterly report.This complaint will be used for tracking and trending purposes.

• Brand Name: TROCAR CATH 28FR
• Common Device Name: TROCAR
• Manufacturer (Section D): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13497705
• Report Number: 9611018-2022-00549
• Device Sequence Number: 11825279
• Product Code: DRC
• UDI-Device Identifier: 10884521029309
• UDI-Public: 10884521029309
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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
• Device Model Number: 8888561068
• Device Catalogue Number: 8888561068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown