MAUDE Adverse Event Report: COVIDIEN STR THOR CATH 28FR; CATHETER AND TIP, SUCTION

Model Number	8888570549
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that they opened a new thoracic catheter 28fr and nothing was in the package.Additional information received from the initial reporter on 6-may-2021 stated that the device was not being used in an emergency situation.There was no significant delay to note.There was no harm or injury to the patient.No medical intervention was required.A new thoracic catheter package was opened.

• Brand Name: STR THOR CATH 28FR
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11837663
• Report Number: 9612030-2021-02907
• Device Sequence Number: 1058826
• Product Code: JOL
• UDI-Device Identifier: 10884521050846
• UDI-Public: 10884521050846
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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: No Information
• Device Model Number: 8888570549
• Device Catalogue Number: 8888570549
• Device Lot Number: 2033637264
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1