MAUDE Adverse Event Report: PERFORMA® NON BRAIDED CATHETER; PERIPHERAL CATHETER

Model Number	00884450001431
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
Account alleges that during a venogram of iliac veins with 3d spins with 100 ml injections through a pigtail, the catheter was found to be fractured upon removal.No patient injury to report.
Additional Manufacturer Narrative
The suspect device has not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and only one similar complaint for this lot number was identified.Should the device be returned later, the investigation will be re-opened.

• Brand Name: PERFORMA® NON BRAIDED CATHETER
• Common Device Name: PERIPHERAL CATHETER
• MDR Report Key: 10680959
• Report Number: 3010665433-2020-00039
• Device Sequence Number: 571697
• Product Code: DQO
• UDI-Device Identifier: 00884450001431
• UDI-Public: 00884450001431
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K000659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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 Expiration Date: 06/30/2023
• Device Model Number: 00884450001431
• Device Catalogue Number: 7602-20M
• Device Lot Number: E1864594
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/18/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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