MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 28FR

Model Number 8888561068

Device Problem Component Missing (2306)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported 1 green trocar catheter had only a needle in the package and no drain.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported 1 green trocar catheter had only a needle in the package and no drain.

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
• Type of Device: 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
• MDR Text Key: 285354294
• Report Number: 9611018-2022-00549
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 10884521029309
• UDI-Public: 10884521029309
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• 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
• Date Manufacturer Received: 02/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1