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

Model Number	8888570549
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that after surgery the surgeon needed to place a chest drain.The surgeon realized before placing the chest drain that the drain did not have any holes at the end of drain tubing.There was no harm to the patient.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One decontaminated sample without original package or lot number was received for the evaluation.After performing a visual inspection, the sample received does not correspond to the component manufactured by cardinal health manufacturing plant.The reported condition could not be confirmed due to the physical sample received does not correspond to the code reported.No corrective actions are deemed necessary at this time.The process is running according to product specifications meeting quality acceptance criteria will be keep monitoring the process for any adverse trends that require immediate attention.

• 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: 9678679
• Report Number: 9612030-2020-02408
• Device Sequence Number: 16743272
• Product Code: JOL
• UDI-Device Identifier: 10884521050846
• UDI-Public: 10884521050846
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: No Information
• Device Model Number: 8888570549
• Device Catalogue Number: 8888570549
• Device Lot Number: 10580415
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1